Systems and methods for treatment of compressed nerves

ABSTRACT

Disclosed herein is a system for releasing a ligament. In one embodiment, the system includes a proximal handle, a tubular body, and a flexible body. The tubular body includes a proximal end and a distal end. The handle is coupled to the proximal end. The flexible body extends through the tubular body and includes a tissue cutting portion. The flexible body is longitudinally displaceable relative to the tubular body to move the tissue cutting portion between a non-deployed state and a deployed state.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 USC §119(e) toU.S. Patent Application No. 61/266,903 entitled “Systems and Methods forTreatment of Carpal Tunnel Syndrome and Plantar Fasciitis” and filedDec. 4, 2009 and to U.S. Patent Application No. 61/232,325 entitled“Systems and Methods for Treatment of Carpal Tunnel Syndrome” and filedAug. 7, 2009, both of which are hereby incorporated by reference intheir entirety.

FIELD

The present disclosure relates to systems and methods for treatment ofcompressed nerves.

BACKGROUND

Carpal tunnel syndrome (CTS) is a painful condition of the handcharacterized by tingling and numbness and loss of grip strength. CTS iscaused by the compression of the median nerve at the carpal tunnel andit is one of the common nerve entrapment syndromes.

As shown in FIG. 1, which illustrates a normal or non-compressed carpaltunnel, the carpal tunnel 5 is the area of the wrist and palm of thehand 10 formed by a U-shaped cluster of bones 15 that form a hard floorand two walls of the tunnel 5. The roof of the tunnel is formed by thetransverse carpal ligament (TCL) 20 which attaches to the wrist bones.Within the confines of the tunnel 5 is the median nerve 25 and theflexor tendons 30 of the thumb and fingers.

As indicated in FIG. 2, which depicts a compressed carpal tunnel, athickening of the TCL 20 and a corresponding narrowing of the size ofthe carpal tunnel 5 may precipitate CTS. This thickening causescompression of the flexor tendons 30 and median nerve 25 which leads toCTS symptoms.

A number of factors may contribute to the thickening of the TCL. Normalwear and tear and repetitive wrist movements may cause thickening of theTCL. Wrist fracture may cause bony narrowing of the tunnel. Pregnancy,obesity, diabetes, thyroid dysfunction and chronic renal failure maypredispose a patient to CTS. CTS generally occurs in people between theages of 30 and 60 and it is more common in females.

Diagnosis of CTS may be established by history and examination. Symptomsmay include nocturnal hand pain. Positive examination findings includenerve irritation signs, such as positive Phalen's wrist flexion test,and Tinel's sign, and weakness and numbness in the median nervedistribution. Electrical studies show prolongation of about 3.5miliseconds is present in many surgically confirmed cases.

Medical management may be by splinting, anti-inflammatories, and steroidinjections in the wrist. If unsuccessful, surgical intervention todecompress or release the TCL may be indicated.

FIG. 3 depicts one type of surgical technique, known as an open releasesurgery. Open surgical decompression by cutting the TCL was firstdescribed in 1930 by Learmonth. The open technique involves creation ofan incision beginning in the palm and extending to the wrist. Throughthis open incision, a surgeon may directly visualize the TCL and may usea scalpel to cut completely through the TCL and release the compressionof the median nerve. Angling the incision towards the ulnar aspect ofthe wrist helps to avoid cutting the palmar sensory cutaneous branch ofthe median nerve. The skin incision can vary in length from one to fiveinches depending upon training and experience but should be sufficientto allow full sectioning of the TCL.

After surgery, the hand is wrapped. The stitches are removed 10 to 14days after surgery. Patients may be directed to wear a splint forseveral weeks. The pain and numbness may go away right after surgery ormay take several months to subside.

However, open incisions require significant time to heal. Also, the skinin the palm is thick and prone to cracking and hand immobilization isnecessary for wound healing. Patients are often advised to avoid heavyuse of their hand for up to 3 months. When a patient's return to work isdependent on the operated hand, rehabilitative physical therapy iscommonly prescribed. Therapy is often prescribed for the resultantsymptomatic scar tissue.

FIG. 4 depicts another type of surgical technique known as an endoscopicrelease surgery. Endoscopic carpal tunnel release is a technicalprocedure that requires microscopic techniques and the correctendoscopic equipment with the necessary back up equipment.

To perform the procedure, anesthetic is administered and an incision ismarked out on the wrist just proximal to the palm. The superficialtendon and small veins are retracted to prevent nerve injury. An ‘L’ or‘U’ shaped incision is made in the first layer called the flexorretinaculum. This layer is lifted up as a flap that forms a doorway intothe carpal tunnel.

A spoon shaped device (such as a synovial elevatoris) is used to cleanthe under surface of the ligament to provide visualization with anendoscope. Dilators help to compress the tissues in the carpal canal tomake it possible to insert the endoscopic device with minimal pressure.The endoscopic device is inserted carefully so that the ligament can beseen along its entire length. Often the device is warmed to preventfogging. Once the ligament is clearly seen, the small blade in thedevice is used to release the ligament in stages, after making sure thatimportant nerves and arteries are protected.

Once the ligament is completely released, the rest of the flexorretinaculum in the wrist is released with a special type of scissors.Local anesthetic is injected for post-operative pain relief and theincision is sutured. A soft bandage is applied for the patient to keepon for two days to reduce swelling. After two days they can remove thelarger dressing and apply a Band-Aid.

This method requires specialized training and a long learning curve.Surgery is longer than the open release procedures and significantinjuries have been reported.

Plantar fasciitis is a painful inflammatory process of the plantarfascia. The plantar fascia is a thick fibrous band of tissue originatingat the bottom surface of the calcaneus (heel bone) and extending alongthe sole of the foot towards the toes. According to one study, plantarfasciitis occurs in two million Americans a year and will occur in 10%of the population over a lifetime. Plantar fasciitis is commonlyassociated with long periods of work-related weight bearing activity,and among non-athletic populations, it is associated with a high bodymass index. Typically, pain is felt on the underside of the heel and onemay suffer from decreased dorsiflexion of the ankle in addition to kneepain. Generally, treatment is non-surgical, although surgical treatmentmay be used. One type of surgical technique may include use of anultrasound guided needle. The needle is inserted into the plantar fasciaand moved back and forth to disrupt the fibrous tissue. Another surgicaltechnique is a coblation surgery (also known as a Topaz procedure). Thistechnique has been used in the treatment of recalcitrant plantarfasciitis and utilizes radiofrequency ablation.

However, known surgical techniques may cause injury to the nerve,infection and may fail to relieve the pain.

There is a need in the art for improved systems and methods for surgicaltreatment of carpal tunnel syndrome and plantar fasciitis with increasedefficiency and reduced surgical complications.

SUMMARY

Disclosed herein is a system for releasing the transverse carpalligament to decompress the median nerve. In one embodiment, the systemincludes an introducer, an elongated body including a blunt tip and acutting member for cutting the transverse carpal ligament to decompressthe median nerve, a neuro-monitoring system operably connected to theelongated body for aiding a surgeon in navigating the elongated bodyunder the transverse carpal ligament, and handle members respectivelyoperably attached to a distal end and a proximal end of the elongatedbody, wherein the handle members are operably attached to the respectivedistal and proximal ends of the elongated body after the elongated bodyis navigated under the transverse carpal ligament and wherein the handlemembers at the distal end and the proximal end of the elongated body areused to guide the cutting member of the elongated body to release thetransverse carpal ligament to decompress the median nerve. In oneembodiment, the system may further include a hand immobilizing system.

Disclosed herein is a method for releasing the transverse carpalligament to decompress the median nerve. In one embodiment, the methodincludes providing an introducer into the deep wrist of a patient'shand, introducing an elongated body into the introducer, the elongatedbody including a blunt tip, a cutting member, a distal end and aproximal end, providing a neuro-monitoring system operably attached tothe elongated body, navigating the elongated body under the transversecarpal ligament to an exit point at a surface of the patient's hand viainput received from the neuro-monitoring system, extending at least aportion of the elongated body through the exit point such that thedistal end of the elongated body is external to the hand, removing theintroducer, providing handle members and operably attaching one handlemember to the distal end and another handle member to the proximal endof the elongated body, and using the handle members to displace thecutting member of the elongated body along the transverse carpalligament to release the transverse carpal ligament thereby decompressingthe median nerve. In one embodiment, the method may further includeproviding a hand immobilizer system to immobilize the patient's handwhile using the handle members to displace the cutting member of theelongated body along the transverse carpal ligament to release thetransverse carpal ligament thereby decompressing the median nerve.

Disclosed herein is a system for releasing the transverse carpalligament to decompress the median nerve. In one embodiment the systemincludes an introducer, a first elongated body including a blunt tip anda cutting member for cutting the transverse carpal ligament todecompress the median nerve, a second elongated body including aproximal end and a distal end having a hook, a neuro-monitoring systemoperably connected to the elongated body for aiding a surgeon innavigating the elongated body under the transverse carpal tunnelligament; and handle members respectively operably attached to a distaland proximal end of the first elongated body, wherein the handle membersare operably attached to the respective proximal and distal ends of thefirst elongated body after the first elongated body is navigated underthe transverse carpal ligament and the second elongated body isnavigated through subcutaneous tissue above the transverse carpalligament and the second elongated body is operably attached to the firstelongated body such that when the second elongated body is withdrawn,the first elongated body creates a loop structure about the transversecarpal ligament and wherein the handle members at the distal end and theproximal end of the first elongated body are used to guide the cuttingmember of the first elongated body to release the transverse carpalligament to decompress the median nerve.

Disclosed herein is a system for releasing the plantar fascia to treatplantar fasciitis in a plantar fascia release procedure. In oneembodiment, the system may include an introducer, an elongated bodyincluding a blunt tip and a cutting member for cutting the plantarfascia in a plantar fascia release procedure, a neuro-monitoring systemoperably connected to the elongated body for aiding a surgeon innavigating the elongated body under the plantar fascia, and handlemembers respectively operably attached to a distal and proximal end ofthe elongated body, wherein the handle members are operably attached tothe respective proximal and distal ends of the elongated body after theelongated body is navigated under the plantar fascia and wherein thehandle members at the distal end and the proximal end of the elongatedbody are used to guide the cutting member of the elongated body torelease the plantar fascia to treat plantar fasciitis in a plantarfascia release procedure.

Disclosed herein is a system for releasing the transverse carpalligament to decompress the median nerve. In one embodiment, the systemincludes an elongated body including a blunt tip and a cutting memberfor cutting the transverse carpal ligament to decompress the mediannerve, a neuro-monitoring system operably connected to the elongatedbody for aiding a surgeon in navigating the elongated body under thetransverse carpal tunnel ligament, a securing member that is operablyattached to a distal end of the cutting member after the elongated bodyis navigated under the transverse carpal ligament and the cutting memberexits a distal end of the elongated body and then exits the hand at anexit point in the palm, and a handle member including an actuatoroperably attached to a proximal end of the elongated body wherein theactuator of handle member at the proximal end of the elongated body isused to guide the cutting member of the elongated body to release thetransverse carpal ligament to decompress the median nerve.

Disclosed herein is a system for releasing the transverse carpal tunnelligament to decompress the median nerve. In one embodiment, the systemincludes an introducer, an elongated body including a proximal end and adistal end, a blunt tip and a cutting member for cutting the transversecarpal ligament to decompress the median nerve, a neuro-monitoringsystem operably connected to the elongated body for aiding a surgeon innavigating the elongated body under the transverse carpal tunnelligament, a piercing member that is operably attached to a distal end ofthe cutting member to pierce the palm at an exit point in the palm ofthe hand as the cutting member exits the distal end of the elongatedbody and then exits the hand at the exit point in the palm, a motionlimiting feature operably connected to the proximal end of the elongatedbody, the motion limiting feature configured to prevent the introducerfrom re-entering an entry point in the palm after withdrawal andconfigured to prevent the elongated body from exiting at the exit pointin the palm, a first handle member operably attached to a proximal endof the elongated body, and a second handle member operably attached tothe piercing member at the distal end of the cutting member after thepiercing member and the cutting member exit the palm of the hand,wherein the first and second handle members are used to guide thecutting member of the elongated body to release the transverse carpalligament to decompress the median nerve. In some embodiments, the firsthandle member may further include an actuator. In some embodiments, thissystem may be used to release the plantar fascia to treat plantarfasciitis.

Disclosed herein is a system for releasing a ligament. In oneembodiment, the system includes a proximal handle, a tubular body, and aflexible body. The tubular body includes a proximal end and a distalend. The handle is coupled to the proximal end. The flexible bodyextends through the tubular body and includes a tissue cutting portion.The flexible body is longitudinally displaceable relative to the tubularbody to move the tissue cutting portion between a non-deployed state anda deployed state.

In one version of the embodiment, the tissue cutting portion includes aplurality of teeth or an abrasive surface. In another version of theembodiment, the tissue cutting portion includes an RF energy cutter or awater jet.

In one version of the embodiment, the flexible body is longitudinallydisplaced relative to the tubular body during a tissue cutting motion.In another version of the embodiment, the flexible body and tubular bodyare moved together during a tissue cutting motion. In yet anotherversion of the embodiment, the flexible body is axially rotationallydisplaced relative to the tubular body during a tissue cutting motion.

In one version of the embodiment, the tubular body further includes awindow, wherein, when the flexible body is longitudinally displacedrelative to the tubular body to move the tissue cutting portion from thenon-deployed state to the deployed state, the cutting portion moves frombeing generally hidden within the tubular body to being generallyexposed in the window.

In another version of the embodiment, the tubular body further includesa window, wherein, when the flexible body is longitudinally displacedrelative to the tubular body to move the tissue cutting portion from thenon-deployed state to the deployed state, the cutting portion moves frombeing generally recessed within the tubular body to being generallyexposed in the window. For example, in such a version, when the cuttingportion is in the deployed state, the cutting portion assumes a bow-likearrangement with the tubular body.

In one version of the embodiment, the system further includes anactuator near the proximal end of the tubular body that causes thecutting portion to move between the non-deployed state and thenon-deployed state. The handle may include the actuator.

In one version of the embodiment, the system further includes a distalhandle configured to operably couple to the distal end of the tubularbody. The flexible body may further include a distal end including atissue penetration tip that moves from a recessed state to a tissuepenetration state when the flexible body is longitudinally displacerelative to the tubular body. When the penetration tip is in therecessed state, the tissue cutting portion is in the non-deployed state.When the penetration tip is in the tissue penetration state, the tissuecutting portion is in the deployed state. In some versions, the distalhandle is configured to operably couple to the distal end of the tubularbody by being directly connected to the distal end of the flexible bodywhen the penetration tip is in the penetration state.

In one version of the embodiment, the system further includes anadjustable lock supported on the tubular body that limits a distalcutting stroke displacement of the system. The distal cutting strokedisplacement of the system may be limited by the adjustable lock suchthat the tubular body will extend through an exit hole created in thepalm by the penetration tip.

In one version of the embodiment, the system further includes a nervesensing system electrically coupled to the tubular body or flexiblebody. The nerve sensing system may be configured to sense nerve impulsesor action potentials. The nerve sensing system may include an ultrasoundprobe operably coupled to the tubular body. The nerve sensing system mayinclude a hardness sensor operably coupled to the tubular body.

Also disclosed herein is a method of releasing a ligament. In oneembodiment, the method includes: percutaneously penetrating at a firstlocation with a tubular body; positioning the tubular body adjacent theligament; employing a nerve sensing system to position a tissue cuttingportion away from a nerve, the tissue cutting portion being part of aflexible body longitudinally displaceable relative to the tubular bodybetween a non-deployed state and a deployed state of the tissue cuttingportion; causing the tissue cutting portion to longitudinally displacefrom the non-deployed state to the deployed state; and releasing theligament with the tissue cutting portion.

Disclosed herein is a system for releasing a ligament. In oneembodiment, the system includes: an introducer including a distal endand a proximal end; a flexible body including a first end, a second endand a length extending between the first end and the second end, thelength forming a loop distally extending from the distal end of theintroducer and configured to have the ligament in the loop, the lengthcomprising a tissue cutting portion, the first end and the second endproximally extending from the proximal end of the introducer. The tissuecutting portion may include a plurality of teeth or an abrasive surface.

In one version of the embodiment, the system further includes anelongated body configured to be extended through the introducer proximalto distal and engage the first end and pull the first end around theligament and through the introducer to form the loop such that the firstend is adjacent the second end extending proximally from the proximalend of the introducer, the elongated body including a first engagementfeature configured to engage a second engagement feature on the firstend. The first engagement feature may include a hook and the secondengagement feature may include a ball. The elongated body may includeforceps.

In one version of the embodiment, the system further includes a firsthandle operably coupled to the first end and a second handle operablycoupled to the second end.

In one version of the embodiment, the system further includes a nervedetection system coupled to the flexible body.

Disclosed herein is a method for releasing a ligament. In oneembodiment, the method includes: percutaneously penetrating at a firstlocation with an introducer including a distal end and a proximal end;providing a flexible body including a first end, a second end and alength extending between the first end and the second end and includinga tissue cutting portion; routing the first end distally through theintroducer, around the ligament and proximally back through theintroducer such that the length forms a loop around the ligament, theloop distally extending from the distal end of the introducer, the firstend and the second end proximally extending from the proximal end of theintroducer; and employing the tissue cutting portion to release theligament. The tissue cutting portion may include a plurality of teeth oran abrasive surface.

In one version of the embodiment, the method further includes employingan elongated body configured to be extended through the introducerproximal to distal to engage the first end and pull the first end aroundthe ligament and through the introducer to form the loop.

In one version of the embodiment, the method further includes securing ahandle to at least one of the first end or second end. In one version ofthe embodiment, the method further includes employing a nerve sensingsystem to position the tissue cutting portion away from a nerve.

Disclosed herein is a handboard assembly for securing a hand and forearmof a patient undergoing a carpal tunnel surgery. In one embodiment, theassembly includes: a chassis base including a first end and a secondend; and a flex board including a third end, a fourth end, a firstplanar region adjacent the third end, a second planar region adjacentthe fourth end and a flex region between the first planar region and thesecond planar region, the third end operably coupled to the first endand the fourth end operably coupled to the second end, the flex regionconfigured to result in a bend in the flex board when the first planarregion and the second planar region are each caused to assume an inclinerelative to the chassis base. The first planar region may be adapted toreceive the hand and the second planar region is adapted to receive theforearm. The first planar region may include a finger receiving portionwith a finger securing mechanism and a thumb receiving portion with athumb securing mechanism, and the second planar region includes aforearm securing mechanism. At least one of the finger securingmechanism, thumb securing mechanism, or the forearm securing mechanismmay include a strap arrangement. The strap arrangement may include hookand loop regions.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. As will be realized, theinvention is capable of modifications in various aspects, all withoutdeparting from the spirit and scope of the present invention.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a non-compressed carpal tunnel area of a wrist andpalm of a hand.

FIG. 2 illustrates a compressed carpal tunnel area of a wrist and palmof a hand.

FIG. 3 depicts an open release surgical procedure being performed on thecompressed carpal tunnel area of FIG. 2.

FIG. 4 depicts an endoscopic release surgical procedure being performedon the compressed carpal tunnel area of FIG. 2.

FIG. 5 illustrates placement of an introducer into the carpal tunnelarea of FIG. 2.

FIG. 6A depicts one embodiment of a release system showing introductionof an elongated body through the introducer into the carpal tunnel areaof FIG. 2.

FIG. 6B illustrates the release system of FIG. 6A, wherein an internalcutting wire or other cutting member is being introduced through theelongated body.

FIG. 6C depicts one embodiment of the elongated body of FIG. 6A, whereina cutting member is also shown.

FIG. 6D is an enlarged view of a segment of the elongated body of FIG.6C.

FIG. 6E depicts another embodiment of the elongated body of FIG. 6A,wherein a cutting member is also shown.

FIG. 6F is an enlarged view of a segment of the elongated body of FIG.6E.

FIG. 6G depicts still another embodiment of the elongated body of FIG.6A wherein a cutting member is also shown.

FIG. 6H is an enlarged view of a segment of the elongated body of FIG.6G.

FIG. 7A depicts another embodiment of the release system, wherein anelongated body is shown connected to one embodiment of a handle member,and the hand and the introducer are not shown for clarity purposes.

FIG. 7B depicts the elongated body of FIG. 7A, wherein one embodiment ofthe internal cutting wire of FIG. 6B is introduced through the elongatedbody.

FIG. 7C depicts the elongated body of FIG. 7A, wherein a cutting memberis shown.

FIG. 7D illustrates the elongated body and handle members of FIG. 7Cwherein the hand is shown.

FIG. 8A depicts another embodiment of the release system, wherein anelongated body is shown connected to one embodiment of a handle memberand the hand and the introducer are not shown for clarity purposes.

FIG. 8B depicts the elongated body of FIG. 8A wherein one embodiment ofthe internal cutting wire of FIG. 6B is introduced through the elongatedbody.

FIG. 8C depicts the elongated body of FIG. 8A, wherein a cutting memberis shown.

FIG. 8D illustrates the elongated body and internal cutting wire of FIG.8B wherein the hand is shown.

FIG. 9A depicts another embodiment of the release system of FIG. 6Bwherein an additional introducer is not shown for clarity purposes.

FIG. 9B illustrates placement of the embodiment of FIG. 9A into thecarpal tunnel area of FIG. 2.

FIG. 9C illustrates the embodiment of FIG. 9B wherein a cutting memberor internal cutting wire is exposed.

FIG. 9D depicts the embodiment of FIG. 9B wherein a securing member isalso shown.

FIG. 9E depicts the embodiment of FIG. 9D wherein the cutting member isshown releasing a transverse carpal ligament (TCL).

FIG. 9E-1 depicts an enlarged view of the cutting member releasing theTCL of FIG. 9E.

FIG. 10A depicts another embodiment of the release system, wherein acutting wire is being introduced into the carpal tunnel area of FIG. 2,and wherein one embodiment of a sled member is shown but an introduceris not shown for clarity purposes.

FIG. 10B is an enlarged view of the sled member of FIG. 10A.

FIG. 10C is a cross-section view of the sled member about section line10-10 of FIG. 10B.

FIG. 10D illustrates placement of the embodiment of FIG. 10A under theTCL.

FIG. 10E depicts the embodiment of FIG. 10A wherein the cutting wire isshown exiting the palm of the hand.

FIG. 10F depicts the system of FIG. 10A wherein a cutting member (notshown) is used to release the TCL.

FIG. 11A depicts another embodiment of the release system, wherein acutting wire is being introduced into the carpal tunnel area of FIG. 2,and wherein another embodiment of a sled member is shown.

FIG. 11B is an enlarged view of the sled member of FIG. 11A.

FIG. 11C is a cross-section view of the sled member about section line11-11 of FIG. 11B.

FIG. 12A illustrates still another embodiment of the system, wherein afirst elongated body is being introduced under the TCL.

FIG. 12B depicts the system of FIG. 12A wherein a second elongated bodywith a hook member is introduced to the subcutaneous tissue above theTCL.

FIG. 12C illustrates the system of FIG. 12B wherein the first elongatedbody has formed a loop structure about the TCL.

FIG. 12D illustrates the system of FIG. 12C wherein a proximal end and adistal end of the first elongated body is operably connected to a handlemember and the TCL is being released.

FIG. 13A illustrates still another embodiment of the system, whereinboth an elongated body and a forceps device have been introduced intothe carpal tunnel area/subcutaneous tissue of FIG. 2.

FIG. 13B is the same view as FIG. 13A except the forceps device hasfully engaged the elongated body.

FIG. 14A illustrates an embodiment of the release system for treatmentof plantar fasciitis, showing placement of an introducer into a foot.

FIG. 14B depicts introduction of an elongated body through theintroducer under a plantar fascia of the foot.

FIG. 14C depicts the elongated body releasing the plantar fascia.

FIG. 15A depicts still another embodiment of a release system having adelivery or deployment instrument, a handle member and a return shaftmember.

FIG. 15B depicts the delivery or deployment instrument of FIG. 15A.

FIG. 15C is the same view as FIG. 15B except a cutting member deliverydevice is also shown.

FIG. 15D is the same view as FIG. 15C except the cutting member deliverydevice is being deployed.

FIG. 15E is an enlarged view of a distal end of the delivery ordeployment instrument of FIG. 15D.

FIG. 15F is still another enlarged view of the distal end of thedelivery or deployment instrument of FIG. 15D.

FIG. 15G depicts the return shaft member of FIG. 15A.

FIG. 15H depicts an enlarged view of a distal end of the return shaftmember of FIG. 15G.

FIG. 15I is a transparent view of the return shaft member of FIG. 15H.

FIG. 15J is a top side view of the return shaft member of FIG. 15H.

FIG. 15K depicts the handle member of FIG. 15A.

FIG. 15L is the same view as FIG. 15K except an abrasive suture materialis also shown positioned on the handle member.

FIG. 16A depicts still another embodiment of a release system includingan introducer and an elongated body.

FIG. 16B depicts the release system of FIG. 16A, wherein handle membersare shown operably connected to the elongated body and the elongatedbody is introduced into the carpal tunnel region of FIG. 2.

FIG. 16C is the same view as FIG. 16B, except a cutting member is shownexiting the palm of the hand.

FIG. 16D is the same view as FIG. 16C, except the cutting member isshown operably connected to a handle member.

FIG. 16E is the same view as FIG. 16D, except the introducer is beingwithdrawn from an entry site in the palm of the hand.

FIG. 16F is the same view as FIG. 16E, except the withdrawn introduceris being held in place by a motion limiting feature.

FIGS. 16G and 16H are the same view as FIG. 16F wherein the cuttingmember is positioned in the carpal tunnel region to release the TCL.

FIG. 17A depicts another embodiment of a release system including ahandboard assembly and handle members.

FIG. 17B-1 depicts an exploded view of the handboard assembly of FIG.17A.

FIG. 17B-2 is a top isometric view of a baseplate chassis of thehandboard assembly of FIG. 17A.

FIG. 17B-3 is a bottom elevation view of the baseplate chassis of FIG.17B-2.

FIG. 17B-4 is a top elevation view of a flexboard of the handboardassembly of FIG. 17A.

FIG. 17B-5 is an isometric view looking from the bottom and side of adrape assembly of the handboard assembly of FIG. 17A.

FIG. 17B-6 is an exploded top elevation view of the drape assembly ofFIG. 17B-5.

FIG. 17C-1 is an isometric view of a proximal handle assembly of thesystem of FIG. 17A.

FIG. 17C-2 is an exploded view of a first side of the proximal handleassembly of FIG. 17C-1.

FIG. 17C-3 is an exploded view of a second side of the proximal handleassembly of FIG. 17C-1.

FIG. 17C-4 is an isometric view of a distal end of a cutting wireassembly of the proximal handle assembly of FIG. 17C-1.

FIG. 17C-5 is an isometric view of a probe wire assembly of the proximalhandle assembly of FIG. 17C-1.

FIG. 17D-1 is an isometric view of a first embodiment of an introducerassembly of the system of FIG. 17A.

FIG. 17D-2 is an isometric view of a second embodiment of an introducerassembly of the system of FIG. 17A.

FIG. 17E-1 is an isometric view of a shaft lock assembly of the systemof FIG. 17A.

FIG. 17E-2 is a side view of the shaft lock assembly of FIG. 17E-2.

FIG. 17E-3 is a cross-sectional elevation of the shaft lock assemblytaken about section line A-A of FIG. 17E-2.

FIG. 17F-1 is an isometric view from the front of a distal handleassembly of the system of FIG. 17A.

FIG. 17F-2 is an isometric view from the back of a distal handleassembly of the system of FIG. 17A.

FIG. 17F-3 is an exploded view of the distal handle assembly of FIG.17F-1.

FIG. 17F-4 is an exploded view of the distal handle assembly of FIG.17F-2.

FIG. 17G-1 is a side view of a distal end of a nerve wire assembly ofthe system of FIG. 17A.

FIG. 17G-2 is an exploded view of the distal end of the nerve wireassembly of FIG. 17G-1.

FIG. 17H illustrates the proximal handle assembly and the distal handleassembly of FIG. 17A operably connected for a release procedure, whereinthe hand is not shown for clarity.

FIG. 18 depicts still another embodiment of a release system including ahandboard assembly and handle members, wherein a nerve detection systemand a different embodiment of a distal handle are also shown.

FIGS. 19A-19E-2 illustrate various additional embodiments of a cuttingmember which may be used with a release system according to the presentdisclosure.

FIGS. 20A-20F illustrate various embodiments of a nerve detection systemwhich may be used with a release system according to the presentdisclosure.

FIGS. 21A-21G illustrate various additional embodiments of a handlemember which may be used with a release system according to the presentdisclosure.

DETAILED DESCRIPTION

Disclosed herein is an incisionless method and system for releasing thetransverse carpal ligament (TCL) to decompress the median nerve. In someembodiments, the method (technique) or system includes needle stickintroducer access into the general carpal tunnel area. An elongated ortubular body, such as a hollow wire or cannula, may be introduced intothe carpal tunnel area through the introducer and a surgeon may safelyguide the elongated body through the compressed carpal tunnel area to anexit point at, near or in the palm of the hand. The elongated body mayinclude cutting members and may include a probe member or the probemember may be a separate instrument. The elongated body may be operablyconnected to a neuro-monitoring device to help the surgeon guide theelongated body into proper placement under the TCL without injuring themedian nerve. An internal cutting wire may be introduced into theelongated body and extended to the exit point where it will exit thepalm such that the distal end of the elongated body can be retrieved andbe operably connected to a handle member. The cutting member(s) orinternal cutting wire may be a flexible body and may include tissuecutting portions. In some embodiments, the cutting members may also bethe tissue cutting portions. In other embodiments, the internal cuttingwire may exit the palm such that the distal end of the wire can beretrieved and be operably connected to a handle member. In someembodiments, the internal cutting wire may include cutting members ortissue cutting portions and a penetration tip. In still otherembodiments, the internal cutting wire may not exit the palm and may beoperably coupled to a second elongated body introduced into the carpaltunnel area. In still other embodiments, an abrasive suture material maybe introduced into the elongated body via a cutting member deliverydevice, such as a needle. The abrasive suture material and the cuttingmember delivery device may be extended to an exit point or opening inthe palm where both will exit the palm. The abrasive suture material maybe operably connected to a handle member.

The hand may be immobilized. In some embodiments, a distal end of anabrasive suture or other cutting member or flexible body may bestabilized or immobilized at the palm of the hand or may be coupled to ahandle member. A proximal end of the abrasive suture or other cuttingmember may also be operably connected to a handle member. The surgeonmay then use the handle member(s) to displace the cutting member (e.g.abrasive suture, internal cutting wire with cutting member or cuttingmember of the elongated body) along the TCL, such that the cuttingmember can release the TCL, such as by cutting, flossing, or sawingthrough the TCL, thereby decompressing the median nerve. Thus, thepresently disclosed system and method do not require a large incision,as required for the open surgery technique, and the specializedequipment and knowledge required for the endoscopic release surgery arealso unnecessary. This may increase the efficiency of the surgery andreduce surgical complications that may result from, for example, a largeopen incision. As explained below in more detail with respect to FIGS.14A-14C, the systems and methods disclosed herein may also be used torelease the plantar fascia in the foot. The systems and methodsdisclosed herein may also be used to decompress the ulnar nerve to treatcubital tunnel syndrome or Guyon's canal syndrome. With cubital tunnelsyndrome, the ulnar nerve is compressed by the humerus bone. The systemas disclosed herein may shave down this bone to relieve compression onthe nerve. Guyon's canal syndrome is compression of the ulnar nerve, by,for example, a cyst or a ligament, e.g. the volnar radio-ulnar ligament.The systems and methods disclosed herein may be used to release thatligament which is compressing the ulnar nerve.

For a detailed description of a system and method for releasing the TCLto decompress the median nerve, reference is first made to FIGS. 5-8D.FIG. 5 illustrates placement of an introducer 35 into the carpal tunnelarea 5 of FIG. 2. FIG. 6A depicts introduction of an elongated body 40through the introducer 35 into the carpal tunnel area 5 of FIG. 2. FIG.6B illustrates an internal cutting wire 47 or other cutting member 45being introduced through the elongated body 40.

As can be understood from FIGS. 5-6B, the system 100 may include anintroducer 35 and an elongated body 40 including a blunt tip 42 and acutting member 45. In some embodiments, the introducer 35 may be a 2 cmintroducer needle (16-18 gauge) that may be inserted through a needlestick access. In some embodiments, the introducer 35 may be a 14 gaugeintroducer needle. It can be appreciated that the introducer 35 may beused in various embodiments described herein but is not required to bepresent throughout the procedure.

The elongated body 40 may be a supple metal wire or a similar sizedcannula or other hollow-type body. In some embodiments, the elongatedbody may be an abrasive material, such as an abrasive suture. Theelongated body 40 may also include cutting member 45. The elongated body40 may have a blunt ball point tip or blunt probe 42 to prevent nerveirritation or nerve or tendon damage as it is passed through the carpaltunnel parallel to the nerve and flexor tendons from proximal to distal.The distal end 43 of the elongated body 40 may naturally assume a curledshape such that when it is passed through the tunnel into the palm, thetip 42 trajectory is upwards towards the palm skin.

The elongated body 40 may have neuro monitoring features, such as asupple metal probe, that may be used in conjunction with neuromonitoring systems or nerve detection systems (see, for example, FIG. 18or FIGS. 20A-20F) to help guide the elongated body 40 through the carpaltunnel area without harming nearby nerves and such that the body 40 isproperly positioned under the TCL. In some embodiments, the neuromonitoring system may be the system offered by Cadwell Laboratories,Inc., Kennewick, Wash., Biotronic, Ann Arbor, Mich. or Medtronic,Minneapolis, Minn. The supple metal probe, such as the blunt probe tip42, is also attached to a nerve monitor to assist the surgeon innavigation under the TCL. It can be appreciated that the probe may alsobe a separate instrument from the elongated body. The surgeon canidentify median nerve irritation and accordingly alter the course of thebody 40 with hand movements or remove the body 40 and start over again.

In various embodiments the body 40 may be partially coated with anon-conductive material such that only a portion of the diameter of thebody 40 is exposed for nerve stimulation.

For a more detailed discussion of the cutting member 45 of the elongatedbody, reference is now made to FIGS. 6C-6H, which illustrate variousembodiments of the cutting member 45. In some embodiments, the cuttingmember may be an abrasive suture material 255 or an internal cuttingwire 47. It can be appreciated that the elongated body 40 may includethe cutting member 45 or the cutting member 45 may be a separate cuttinginstrument that is passed or inserted over or through the elongated bodyto a site below the TCL. That is, and as discussed in more detail below,in some embodiments, the cutting member 45 may be integral with theelongated body 40 and the elongated body is operably attached to atleast one handle member, while in some embodiments, the cutting member45 may be displaceable with respect to the body while the body remainsin a fixed location or is in a stationary position, and in still otherembodiments, the cutting member 45 may be separate from and displaceablewith respect to the body such that the cutting member 45 is operablyattached to the handle members.

As can be understood from FIGS. 6C and 6D, the cutting member 45 may becoated with non-conductive smooth material on three sides with theexposed metal surface having multiple shark teeth, single tooth,abrasive surface, or long sharp surface that is electrified. If thecutting member comes in contact with the nerve, it will be detected bythe nerve monitor. If there is nerve stimulation, the surgeon can adjustor alternatively re-pass the elongated body 40. The cutting member maythen be used to saw or cut through the ligament.

In some embodiments, the cutting member 45 may be a round, triangularshaped or other configuration such that surgeon can recognize thedirectional surface that cuts and accordingly hold the elongated bodysuch that the surface of the cutting member is in contact with the TCL.

As shown in FIGS. 6E and 6F, in one embodiment, there is no coating onthe elongated body and the cutting member has exposed teeth placed alonga substantial length of the elongated body such that the entire TCLcould be released through a single unidirectional pull of the elongatedbody.

As can be understood from FIGS. 6G and 6H, the cutting member 45 may beexposed through the body 40 via only a small window 46 where the body 40is not coated with a non conductive material. The size of this smallwindow 46 corresponds with the proximal/distal length of the TCL beingcut/released. By exposing a smaller cutting surface, the risk of nerveirritation or damage is reduced.

As can be understood from FIGS. 6C-6H and 16A-H (and others), in someembodiments where the cutting member is not a part of the body 40, thebody may have a window cut out on one dorsal surface. The window is thesame length or smaller then the proximal to distal length of the TCL.The window is positioned under the TCL. A cutting member with a singletooth, multiple teeth, sharp or abraded surface or other element forcutting is passed through the body that cuts only at or near the site ofthe window.

As discussed in more detail below and with reference to, for example,FIGS. 15A-15L and FIGS. 19A-19E-2 (and others), in some embodiments, thecutting member 45 (which may be an abrasive suture or other abrasivematerial 255) may be separate from and displaceable with respect to thebody such that the cutting member 45 is operably attached to a handlemember while the body 40 is at or below, but does not exit, the exitpoint of the hand 10. In some embodiments, the elongated body may be anabrasive material and may be operably connected to handle members (seeFIGS. 12A-12D).

As can be understood from FIG. 6B, once the elongated body 40 has beenintroduced under the TCL and extended to an appropriate exit point 51 inthe palm, a stylet or internal cutting or piercing wire 47 may beadvanced to the distal end 43 of the elongated body 40. This cuttingwire 47 may exit a port 44 in the ball point tip 42 and pierce the skinon the palm for access to the distal end 43 of the elongated body 40.

In other embodiments, the ball tip 42 can emit a light that can beidentified in the subcutaneous tissues and a small stab wound made toretrieve the probe 42 and deliver the cutting wire 47 or cutting member45 to the surface.

The surgeon may grasp the distal end 43 of the elongated body 40 and,together with the proximal end of the elongated body, both ends of theelongated body may be operably connected to handle members. In someembodiments, the surgeon may instead grasp the distal end of the cuttingmember 45 or cutting wire 47 that has extended through the exit point ofthe hand and both the distal end of the cutting member 45 or wire 47 andthe proximal end of the elongated body may be operably connected tohandle members. In still other embodiments, the distal end of thecutting member 45 or the elongated body 40 may not exit the palm at theexit point but may be operably attached to a second elongated bodyintroduced into the carpal tunnel region. The second elongated body maybe used to withdraw the distal end of the first elongated body throughthe wrist entry point such that both the proximal and distal ends of thefirst elongated body may be operably connected to a handle member(s). Insome embodiments, both the distal and proximal ends of the cuttingmember 45 or wire 47 may be operably connected to handle members 50.

For a more detailed discussion of the handle members, reference is nowmade to FIGS. 7A-8D and 21A-21G, which depict various embodiments of thehandle members 50 of the system 100. As can be understood from FIGS.7A-8D, the elongated body 40 may be exposed at both its proximal anddistal ends. The elongated body 40 is placed underneath the TCL suchthat the ligament can be cut through a back and forth sawing action bythe cutting member 45. In embodiments where the cutting member is aseparate instrument, the distal and proximal ends of the separatecutting instrument may be operably connected to the handle members andthe sawing or cutting motion happens as described below. That is,although FIGS. 7A-8D show handle members attached to the body 40, inother embodiments, the handle members 50 may be operably attached to thecutting member 45 or internal cutting wire 47. This sawing/cuttingaction is achieved by pulling the elongated body or the cutting memberback and forth.

As shown in FIGS. 7A-7D, in one embodiment, the handle members 50 may begrip handles with an actuator 55. As can be understood from FIGS. 7A-7C(the hand is not shown for clarity), a first grip handle member 50includes the actuator 55 in a channel 56, and the actuator 55 may bedisplaced relative to the grip handle 50, thereby extending the internalcutting wire 47 and exposing the cutting member 45 in the window 46. Asshown in FIGS. 7C and 7D, the elongated body 40 and internal cuttingwire 47 are operably connected to a second handle member 50. Asindicated in FIG. 7D (which shows the system in the hand), the actuator55 is displaced relative to the first handle member within the channel56, thereby inducing a cutting, sawing or other motion to release theTCL to decompress the median nerve.

As illustrated in FIGS. 8A-8D, in one embodiment, the handle member 50may be a trigger grip handle that first extends the external cuttingwire 47 such that the cutting member 45 is exposed within the window 46and then the internal cutting wire 47 is pulled back and forth throughfinger/hand actuated trigger grips while the body remains in location.Because the cutting member 45 is properly placed under the TCL, the backand forth movement of the cutting member will release the TCL therebydecompressing the median nerve.

As can be understood from FIGS. 21A and 21C-G, the elongated body 40 maybe exposed at both its proximal and distal ends. The elongated body 40is placed underneath the TCL such that the ligament can be cut through aback and forth sawing action by the cutting member 45. As can beunderstood from FIG. 21 B, in embodiments where the cutting member 45 isa separate instrument, the distal and proximal ends of the separatecutting instrument may be operably connected to the handle members 50and the sawing or cutting motion happens as described herein. That is,although FIGS. 21A and 21C-G show handle members attached to the body40, in other embodiments, as shown in FIG. 21B (and others), the handlemembers 50 may be operably attached to the cutting member 45. Thissawing/cutting action is achieved by displacing the cutting member. Instill other embodiments where the cutting member 45 is a separateinstrument, for example FIGS. 17A-17H, a proximal end of the elongatedbody 40 may be operably attached to a handle member 50 and a distal endof the cutting member 45 may be operably attached to a second handlemember 50.

FIGS. 21A and 21B illustrate embodiments of the system including handlemembers 50 and a neuro-monitoring or nerve detection system 500. As canbe understood from FIG. 21A, the system 100 may also include shorthollow metal tubes 60 that can be placed onto the proximal and distalportions of the hand and positioned through the skin surface to preventskin laceration from the elongated body 40 as the cutting member isdisplaced to saw or cut through the TCL. As can be understood from FIG.21B, in some embodiments, the cutting member 45 may be separate from anddisplaceable with respect to the body 40 such that the cutting member 45is operably attached to the handle members while the body 40 is affixed,for example by an adhesive attachment 61, 62 of the distal and proximalends of the body 40 to the entry and exit points of the hand 10.

As shown in FIGS. 21A and 21B, the handle members 50 may be elongatedoval shaped handles which may provide feedback to the surgeon's fingersor fine motor skills during the sawing or cutting motion as describedherein.

As indicated in FIG. 21C, in one embodiment, the handle members 50 maybe D shaped handles which may also provide feedback to the surgeon'sfingers/fine motor skills during the sawing/cutting motion.

As illustrated in FIG. 21D, in one embodiment, the handle members 50 maybe trigger grip handles that pull the elongated body 40 back and forththrough finger/hand actuated trigger grips. In another embodiment, thetrigger grip handles may pull the cutting member 45 back and forththrough finger/hand actuated trigger grips while the body 40 remains inlocation.

As indicated in FIG. 21E, in one embodiment, the handle members 50 maybe rotating knobs that are anchored on a hand stabilization system 2100.The knobs facilitate a controlled back and forth movement of theelongated body. The hand stabilization system 2100 may be a sterile handimmobilizer that rigidly fixates the hand such that sawing, flossing orsingle pull through maneuvers by the surgeon do not move the wrist andinadvertently reposition the wire or cutting member under the TCL, onceit has been safely positioned. See FIGS. 17A-18 for additionalembodiments and discussion related to hand immobilization orstabilization systems.

As can be understood from FIG. 21F, in one embodiment, the handlemembers 50 may be a rotating wire belt for the elongated body 40 andfurther utilizing a hand stabilization system 2100.

As shown in FIG. 21G, in one embodiment, the handle members 50 may behand levers that utilize a hand stabilization system 300 and facilitateback and forth movement of the elongated body 40.

For a more detailed discussion of the embodiments where the elongatedbody 40 may not exit at the exit point of the hand, reference is nowmade to FIGS. 9A-13B, which depict various embodiments of the system inwhich the distal end of the elongated body does not exit the palm of thehand.

As can be understood from FIGS. 9A-9E, the handle member 50 may be aflat introducer with an actuator 55. As indicated in FIGS. 9A-9B, theelongated body 40 is inserted via an introducer (see, for example, FIG.5) and the actuator 55 is in a first position. As shown in FIGS.9C-9E-1, the elongated body 40 may be flexible such that after insertionunder the TCL, it may curl at least slightly at its most distal tip 60.The actuator 55 is displaced relative to the handle member and theinternal cutting wire 47 or cutting member 45 extends from the window46, thereby forming a “bow” shape, as can be understood from FIG. 9E-1.A distal end of the external cutting wire 47 or cutting member 45 mayextend through the exit point of the hand and may be held in place by asecuring member 65. The securing member may be a pin, a needle, a wire,an adhesive or other appropriate securing member, or a combinationthereof. In one embodiment, the securing member 65 may be coupled to thecutting wire 47 or cutting member 45 after the cutting wire 47 orcutting member 45 has exited the exit point in the hand 10. In someembodiments, the securing member 65 may be coupled to the internalcutting wire 47 or cutting member 45 within the elongated body 40 (seee.g. FIGS. 15C-15F). Once the distal end of the cutting wire or cuttingmember is secured at the palm of the hand by the securing member 65 (ora combination of securing members), the actuator 55 is moved between thefirst and second positions thereby raising and lowering the “bow” (seeFIG. 9E-1) created by the internal cutting wire 47 or cutting member 45and the elongated body 40 is moved in a sawing, cutting or other motion,thereby releasing the TCL and decompressing the median nerve.

As can be understood from FIGS. 10A-10F and 11A-11C, the internalcutting wire 47 may be received by a sled member 70. As shown in FIGS.10A-10C and 11A-11C, the sled member 70 may have a variable length andincludes a channel 77 that is configured to receive the internal cuttingwire 47. In some embodiments, the sled member may be configured toreceive the elongated body 40 which may be an abrasive material orabrasive suture as described in other embodiments. In some embodiments,the sled member may be configured to receive a cutting member 45 asdescribed herein. The distal end 75 of the sled member 70, which may berounded (FIG. 11A-11C) or slightly pointed (FIGS. 10A-10C), is at aslight slope or incline relative to the proximal end 80 of the sledmember 70 thereby creating an upslope trajectory to facilitate exit ofthe cutting wire 47 from the palm of the hand once the sled member isproperly positioned under the TCL (see FIG. 10D). As shown in FIG. 10B,the sled member 70 may also include a retaining member 75, such as agroove snap, to retain the cutting wire 47 in the channel 77 of the sledmember 70. As indicated in FIGS. 10E and 10F, the internal cutting wire47 may then be extended from the distal end of the sled member and exitthe palm of the hand at the exit point, and secured by a securing member65 or other appropriate device (e.g. a handle member). The cutting wire47 is now properly positioned beneath the TCL and is moved in a sawing,cutting or other motion, thereby releasing the TCL and decompressing themedian nerve.

As can be understood from FIGS. 12A-12D, the elongated body 40 may beintroduced through an introducer 35 into the carpal tunnel region andinto its proper position beneath the TCL but without exiting the hand 10(FIG. 12A). As indicated in FIG. 12B, a second elongated body 85 havinga hook end 90 is introduced through the introducer 35 into thesubcutaneous tissue above the TCL. The hook end 90 of the secondelongated body 85 is advanced towards the distal end 43 of the elongatedbody 40, such as the ball point tip 42 of the elongated body 40, andcoupled to the distal end 43 of the elongated body 40. In someembodiments, the first elongated body 40 and/or the second elongatedbody 85 may be formed of an abrasive material such as abrasive suturesand introduced to the carpal tunnel region via a sled member 70 asdiscussed above with reference to FIGS. 10A-11C.

As can be understood from FIG. 12C, the second elongated body 85 iswithdrawn through the introducer, thereby pulling the first elongatedbody 40 through the subcutaneous space above the TCL and creating a loopstructure 95. A cutting member may be exposed within the loop structureto facilitate release of the TCL. As shown in FIG. 12D, a proximal end92, and a distal end 43 of the elongated body 40 is coupled to a handlemember 50 and each handle member 50 is displaced in the oppositedirection relative to the other to create a sawing or cutting motion asthe loop structure 95 releases the TCL thereby decompressing the mediannerve.

As can be understood from FIGS. 13A-13B, the elongated body 40 may beintroduced through an introducer 35 into the carpal tunnel region andinto its proper position beneath the TCL but without exiting the hand10. In some embodiments, the elongated body may be an abrasive material,such as an abrasive suture. As shown in FIG. 13A, a forceps device 105may also be introduced through the introducer 35 into the subcutaneoustissue above the TCL. As indicated in FIG. 13B, the distal end 110 ofthe forceps 105 is coupled to the ball point tip 42 of the elongatedbody 40 to securely hold the elongated body 40 about the TCL. Theforceps device 105 may be withdrawn subcutaneously, thereby pulling theelongated body 40 into the subcutaneous space above the TCL and creatinga loop structure, as described above with reference to FIGS. 12C and12D. A cutting member 45 may be exposed at the loop of the loopstructure. The proximal and distal ends of the elongated body 40 may beattached to a handle member (such as those depicted in FIGS. 7A-8D or21A-21G) and the elongated body may be displaced in a sawing or cuttingmotion. The sawing or cutting motion releases the TCL therebydecompressing the median nerve.

For a discussion of an embodiment that may be used to treat plantarfasciitis through plantar fascia release, reference is now made to FIGS.14A-14C. As can be understood from FIGS. 14A-14B, an elongated body 40may be introduced through an introducer 35 into the foot 115 andunderneath the plantar fascia 120. The distal end and proximal end ofthe elongated body 40 may be coupled to handle member(s) (such as thosedepicted in FIGS. 7A-8D or 21A-21G or elsewhere in this disclosure). Thedistal and proximal ends of the elongated body 40 may be displaced in acutting or sawing motion thereby releasing the plantar fascia (FIG. 14C)and decreasing the inflammation. It can be appreciated that otherembodiments disclosed herein in the context of treatments for carpaltunnel syndrome may be adapted to treat plantar fasciitis withoutdeparting from the spirit and scope of the disclosure.

For a discussion of another embodiment of a system where the elongatedbody is not required to exit the exit point of the hand, reference isnow made to FIGS. 15A to 15L which depict a complete system in which thedistal end of the elongated body does not exit the palm of the hand.

FIG. 15A illustrates one embodiments of a release system. As can beunderstood from FIG. 15A, in one embodiment, the complete system 200includes a deployment or delivery instrument 205, a return shaft device210 and a handle member 50. The system 200 may also include nervestimulation equipment or a nerve detection device 500 as describedherein.

FIG. 15B illustrates the deployment or delivery instrument 205 whereinan elongated body 40 is shown. FIG. 15C illustrates the deployment ordelivery instrument 205 wherein the elongated body 40 is showntransparent such that a piston 220 and a cutting member delivery device222 may be seen. As shown in FIGS. 15B-15C, and with reference to FIGS.15D-15F, the deployment or delivery instrument 205 may include anelongated body 40, a deployment device handle member 50 a, an actuator55 and a cutting member delivery device 222. The elongated body 40 mayalso be configured to receive a piston 220 therein. The actuator 55 andelongated body 40 may be similar to the same elements as describedelsewhere in this disclosure. The cutting member delivery device 222 maybe a needle, pin or other appropriate device that can deliver anabrasive suture 255 through the deployment or delivery instrument 205.The deployment device handle member 50 a may be similar to one of thehandle members 50 as described elsewhere in this disclosure. The cuttingmember delivery device 222 may be coupled to an abrasive suture, wire orother abrasive material 255 (see FIG. 15L).

FIG. 15D illustrates deployment of the cutting member delivery device222. FIG. 15E is an enlarged view of a distal end 225 of the elongatedbody 40 wherein the cutting member delivery device 222 and piston 220are shown prior to engagement of the piston 220 with the cutting memberdelivery device 222. FIG. 15F is an enlarged view of FIG. 15E. As can beunderstood from FIGS. 15D-15F, as the actuator 55 is displaced towardsthe handle member 50 a, the piston 220 extends through the elongatedbody 40 into engagement with (but not coupling with) the cutting memberdelivery device 222, thereby pushing the cutting member delivery device222 beyond the distal end 225 of the elongated member 40 to the exitpoint in the palm and outside of the palm of the hand. The suture 255may be passed through the piston 220. Once the cutting member deliverydevice 222 has exited the palm, the deployment handle 50 a is retrievedor withdrawn from the device.

FIG. 15G illustrates the return shaft device 210. FIG. 15H illustratesan enlarged view of a distal end 230 of the device 210 wherein a devicepocket 225 is shown. FIG. 15I depicts an enlarged view of the distal end230 of the device 210 wherein the device pocket 225 is transparent suchthat the cutting member delivery device 222 can be seen. FIG. 15J is atop plan view of FIG. 15H. As can be understood from FIGS. 15G-15J, thereturn shaft device 210 may include a handle member 50 b, an elongatedbody 40 b and a cutting member delivery device pocket 225 at a distalend 230 of the device 210 (FIG. 15G). The handle member 50 b and theelongated body 40 b may be as described above. As shown in FIGS. 15H and15J, the device pocket 225 is generally cylindrical in shape andincludes an axial opening 240 defined therein. The opening 240 isconfigured to receive the cutting member delivery device 222 and mayextend less than the length of the device pocket 225. The opening 240may be configured to receive securing devices of various dimensions andthe dimensions of the opening 240 can be adapted accordingly. As shownin FIG. 15I the distal end 245 and the proximal end 250 of the device222 are placed into the opening 240, thereby securing the device 222within the chamber. The abrasive suture material 255 may be outside ofthe opening 240. In some embodiments, the distal end 245 may be placedin the opening 240 first. In some embodiments, the proximal end 250 maybe placed in the opening 240 first. In other embodiments, both theproximal and distal ends 250, 245 may be placed in the openingsimultaneously.

With reference to FIGS. 15D-F, once the device 222 has been deliveredoutside the palm, the handle 50 a is retrieved or withdrawn from thehand. The device 210 is introduced when the device 222 is outside thepalm. The device 222 is received in the device 210 at the opening 240and the suture 255 trails outside of the opening 240. As can beunderstood from FIG. 15J, the return shaft 210 is then navigated backthrough the puncture in the palm, navigated above the TCL and outthrough the original puncture site near the wrist, thereby “wrapping”the suture 255 around the TCL.

FIG. 15K depicts a suture handle member 215. FIG. 15L illustrates amethod of wrapping the suture 255 about the handle member 215. As can beunderstood from FIGS. 15K-15L, the suture handle member 215 may be asolid cylindrical shape and may include two suture receiving slits 260.A first suture receiving slit 260 a is configured to receive a first end255 a of the suture 255 and the suture is then wrapped around the handlethrough a second suture receiving slit 260 b.

With reference to FIGS. 15K-15L, in use, once the return shaft device210 has exited the puncture site in the wrist, the suture material 255is cut so there are two suture lines (the proximal and distal ends ofthe suture 255 a, 255 b). Each of the suture lines 255 may be attachedto a suture handle member 215 as described above. The surgeon now hasboth ends 255 a, 255 b of the suture wrapped around a respective handle215 and can saw, cut, floss or otherwise release the TCL, therebydecompressing the median nerve. At completion of the procedure, thesuture 255 is cut and removed.

For a discussion of another embodiment of a system where the elongatedbody and the introducer do not exit the exit point of the hand,reference is now made to FIGS. 16A to 16H, which depict a release systemin which neither the distal end of the elongated body nor the introducerexit the exit point in the palm of the hand.

As can be understood from FIG. 16A, an introducer 35 is introduced at anentry point 300 in the palm of the hand 10. The introducer 35 may be a10-12GA introducer needle. As shown in FIGS. 16A and 16B, an elongatedbody 40 including handle members 50 c, 50 d at a proximal end 305 of thebody 40 and a window 46 is introduced into the palm of the hand throughthe introducer 35 and guided under the TCL by a neuro-monitoring system(not shown). In some embodiments, the handle member 50 d may be anactuator 55.

As indicated in FIG. 16C, the handle members 50 c, 50 d at a proximalend 305 of the elongated body 40 are snapped together or otherwisecoupled together, thereby extending the cutting member 45 through anexit point 310 in the palm of the hand 10. In some embodiments, thecutting member 45 may include a piercing member 315, such as a needle ora pin to pierce the skin at the exit point 310 in the palm of the hand10. Coupling the handle members 50 c,50 d also exposes the cuttingmember 45 in the window 46 of the elongated body 40.

As shown in FIG. 16D, the piercing member 315 of the cutting member 45is received in the handle member 50 e and the elongated body 40 does notexit the exit point 310 of the hand 10. As indicated in FIG. 16E, theintroducer 35 is withdrawn from the entry point 300 of the palm of thehand 10.

As can be understood from FIGS. 16F-16H, the handle member 50 e isclosed about the distal end 312 of the cutting member 45 therebysecuring the cutting member 45 within the handle member 50 e. Thesurgeon may now grasp the handle members 50 and can saw, cut, floss orotherwise release the TCL, thereby decompressing the median nerve.

As shown in FIGS. 16F-16H, a motion limiting feature 320 is operablyconnected to the elongated body 40 and operates to hold the introducer35 in place such that during the TCL release procedure, the introducer35 will not further puncture the hand. As indicated in FIGS. 16G and16H, the motion limiting feature also prevents the distal end of theelongated body 40 from exiting the palm of the hand. Upon completion ofthe procedure, the handle member 50 e may be removed, the cutting member45 may be retracted and the release system may be removed. In otherembodiments, the cutting member 45 may be simply “clipped off” and thesystem removed.

For a discussion of another embodiment of a system where the elongatedbody and the introducer do not exit the exit point of the hand,reference is now made to FIGS. 17A to 17H, which depict a release systemin which neither the distal end of the elongated body nor the introducerexit the exit point in the palm of the hand.

As can be understood from FIG. 17A, which is an isometric view of thesystem 700, in one embodiment, the release system 700 may include handlemembers 50 (also referred to as a proximal handle assembly 765 and adistal handle assembly 830), an introducer 35 (also referred to as anintroducer assembly 805), and a motion limiting feature 320 (alsoreferred to as a shaft lock assembly 820). In some embodiments, theproximal handle assembly 765 may also include an elongated body 40 witha window 46 (also referred to as a probe wire assembly 780) and acutting member 45 (portions of a cutting wire assembly 790). In someembodiments, the system 700 may include a hand immobilization device,such as a handboard assembly 705 and a drape assembly 750. In someembodiments, the handboard assembly 705 may also include at least onecavity 714 configured to receive a nerve detection system or a neuromonitoring system 500.

As shown in FIG. 17B-1, the handboard assembly 705 includes a baseplatechassis 710, a handboard flexboard 730 and a drape assembly 750. Thehandboard assembly 705 is configured to receive a patient's hand and tohold the hand steady during a release procedure. The baseplate chassis710, the handboard flexboard 730 and the drape assembly 750 may bemanufactured as separate pieces and operably connected as indicated inFIG. 17A (or as indicated in a different embodiment, shown in FIG. 18A).The baseplate chassis 710 may be made of steel or steel alloy or otherappropriate material. The handboard flexboard 730 may be made ofpolypropylene or other appropriate material. The drape assembly 750 maybe made of SMS (spunbound-meltdown-spunbound) material (a syntheticblown fabric) or other appropriate material (e.g. other non-wovenmaterials) and the tabs 754 may be nylon Velcro straps or otherappropriate material.

As indicated in FIGS. 17B-2 and 17B-3, which show top and bottomisometric views of the baseplate chassis 710, the chassis 710 has afirst end 718 and a second end 720 and is generally rectangular inshape. The chassis 710 may also include pin slots 717, a first cavity714 configured to receive a nerve detection system or neuro-monitoringdevice 500, a second cavity 722, a plurality of feet 712 and a pluralityof openings 716 configured to selectively receive a foot 712. The secondcavity 722 is configured to receive or at least not hinder the movementof the distal handle of the release system when the system is in use.

As shown in FIG. 17B-2, in one embodiment, the first end 718 of thechassis 710 includes two first cavities 714 configured to receive anerve detection system 500. In other embodiments, there may be a singlefirst cavity or more than two cavities. In some embodiments, the chassis710 may not include a cavity 714.

As indicated in FIG. 17B-2, the chassis 710 also includes pin slots 717configured to removably receive the ends of the handboard pin 745 oncethe handboard pin 745 has been assembled with the flexboard 730 (seediscussion below with respect to FIG. 17B-4). The second end 720 of thechassis 710 includes six pin slots 717 on each of the left and rightsides 724, 726 of the chassis 710. The first end 718 of the chassis 710includes one pin slot 717 on each of the left and right sides 724, 726of the chassis 710. The handboard pin 745 may be selectively positionedin any of the pin slots 717 as needed for proper positioning of the handduring a release procedure. In other embodiments, the chassis 710 mayinclude greater than seven slots 717 on each side or fewer than sevenslots 717 on each side. In some embodiments, the slots 717 may belocated in other positions about the chassis 710, such as closer to themiddle of the respective sides of the chassis 710.

As shown in FIG. 17B-3, the feet 712 are generally mushroom-shaped andmay be made of rubber or other appropriate material. The feet 712 areremovably coupled to the chassis 710. When operably connected to thebaseplate chassis 710, the feet 712 are configured to hinder or reducemovement of the chassis 710 while the release system is in use. In oneembodiment, four feet 712 may be used. In other embodiments, less thanfour feet or more than four feet may be used. In some embodiments, thefeet 712 may be a different shape such as rectangular or oval or otherappropriate shape. In some embodiments, the feet 712 may be integrallyformed with the chassis 710.

As indicated in FIG. 17B-3, the second end 720 of the chassis 710includes six openings 716 on each of the left and right sides 724, 726of the chassis 710. The first end 718 of the chassis 710 includes oneopening 716 on each of the left and right sides 724, 726 of the chassis710. A foot 712 may be selectively positioned in any of the openings 716as needed for balancing of the chassis 710 or to hinder or reducemovement of the chassis 710 during use. In other embodiments, thechassis 710 may include greater than seven openings 716 on each side orfewer than seven openings 716 on each side. In some embodiments, theopenings 716 may be located in other positions about the chassis 710,such as down a center line of the chassis 710. In some embodiments, thechassis 710 may not include openings 716 such as where the feet 712 areintegrally formed with the chassis 710.

As shown in FIG. 17B-4, which is a bottom elevation view of thehandboard flexboard 730, the flexboard 730 is generally rectangular inshape and includes a first end 732 and a second end 734, which generallycorrespond in width to and generally align with the ends 718, 720 of thechassis 710. The flexboard 730 additionally includes arms 736, 738extending from opposite sides of the flexboard 730, a flex strip 740,drape slots 742 and pin openings 744.

As can be understood with reference to FIG. 17B-1, the arms 736, 738extending from the flexboard 730 also include drape slots 742 and thusare configured to accept a portion of the drape assembly 750. As shownin FIG. 17B-4, the flexboard 730 also includes drape slots 742configured to receive a portion of the drape assembly 750.

As shown in FIG. 17B-4, the flex strip 740 extends transversely acrossthe flexboard 730 and is configured to allow the flexboard 730 to angleor arc or bend when the flexboard 730 is coupled to the chassis 710.This bend encourages proper placement and alignment of a patient's handduring the TCL release procedure (i.e. the patient's hand moves fromflexion to extension).

As indicated in FIG. 17B-4, and with reference to FIGS. 17A, 17B-1 and17B-2, the pin openings 744 are configured to receive a handboard pin745. Once the handboard pin 745 is inserted, the flexboard 730 may beremovably attached to the chassis 710 in any of the pin slots 717 asneeded for proper positioning of the hand during a release procedure.

FIGS. 17B-5 and 17B-6 depict a bottom isometric view and an explodedview from a top elevation perspective of the drape assembly 750. As canbe understood from FIGS. 17B-5 and 17B-6, in one embodiment, the drapeassembly 750 includes a drape body 752 and tabs 754. The drape body 752includes a first end 756, a second end 758 and arms 760. The drape body752 is generally rectangular in shape, with generally rectangularlyshaped arms 760, and the width of the drape body 752 at each end 756,758 generally corresponds to the width of the flexboard 730 and thechassis 705. The drape body 752 may be made of SMS material and the tabs754 may be nylon Velcro straps.

As shown in FIGS. 17B-5 and 17B-6, the tabs 754 are generallyrectangular in shape and include a drape end 759 and a flexboard end760. The drape end 759 of the tabs 754 may be different. That is, tabs754 a may include a slightly raised, hollow box 759 a at the drape end759. This slightly raised, hollow box 759 a is the attachment surface ofthe tab 754 a. Tabs 754 b may include a lip 759 b at the drape end 759.The lip 759 b is the attachment surface of the tab 754 b The tabs 754may be operably connected to the drape body 752 by velcro or otheradhesive, such as glue or tape or by other appropriate attachmentfeatures. In some embodiments, the tabs 754 may also include a referenceor other informative direction to assist the user in assembling therelease system (i.e. connecting the disposable drape body to theflexboard) and/or for securing the patient's hand to the handboardassembly 705.

In use, the handboard assembly 705 is assembled by placing the feet 712in the desired openings 716 of the chassis 710 and the tabs 754 areoperably connected to the drape body 752 and the drape body 752 isoperably attached to the flexboard 730 by via the tabs 754 which arereceived in their respective drape slots 742. Any or all of these stepsmay have been previously completed by the manufacturer. The tabs 754 mayalso be used to secure the patient's hand to the handboard assembly 705.The handboard pins 745 are also inserted into their respective openings744 and the flexboard 730 with drape assembly 750 may now be operablyand removably attached to the chassis 710. In one embodiment, the ends734, 720 are attached first to allow the user to determine the desiredangle at which to bend the flexboard 730 at the flex strip 740. Theangle or arc is determined based on the desired flexion of the hand.Once the desired angle is found, the other end 732 of the flexboard 730,with drape assembly 750 attached, may now be operably and removablyattached to the slots 717 at the end 718 of the chassis 710.

As can be understood from FIG. 17C-1, which depicts the proximal handleassembly 765 in a non-deployed state, the handle assembly 765 includes ahandle 770 having a slider channel 769, a probe wire assembly 780 and acutting wire assembly 790. The handle may be made of polycarbonate orother appropriate material. As shown in FIGS. 17C-2 and 17C-3, whichdepict a partially exploded view of each side of the proximal handleassembly 765, the handle 770 includes a slider end 771, a probe end 772,a saw wire channel 773 extending axially through the handle 770, balldetent openings 774, ball detents 775, female fastening members 776 andmale fastening members 777. Female fastening members 776 are configuredto receive male fastening members 777, thereby joining each side of thehandle 770. Additional fastening members (not shown) such as screws orpins may be used to further secure the female and male fastening members776, 777. In some embodiments, the handle assembly 765 may also includewiring (nerve wire assembly 850 and see 550 on FIG. 18) configured toelectrically couple components of the handle assembly 765, such as theprobe wire assembly 780, with a neuro-monitoring or nerve detectiondevice 500.

As indicated in FIGS. 17C-2 and 17C-3, the cutting wire assembly 790includes a needle saw wire 792 and a needle saw wire slider 794. The sawwire 792 and saw wire slider 794 may be made of steel, a steel alloy orother appropriate material. The needle saw wire 792 includes a sliderend 796 and a distal end 797. The slider end 796 of the needle saw wire792 is coupled to the slider 794 by laser welding or other appropriatemethod. The needle saw wire slider 794 provides a gripping or pushingsurface by which the user can extend and retract the needle saw wire 792from a non-deployed to or from a deployed state. The saw wire channel773 extending axially through the handle 770 is configured to receivethe saw wire 792 as it extends through the handle as the slider 794transitions from a non-deployed state (see FIG. 17C-1) to a deployedstate (see FIG. 17H) and back to a non-deployed state.

As can be seen in FIG. 17C-2, the slider 794 includes an opening 795configured to receive the ball detents 775. As indicated in FIGS. 17C-2and 17C-3, the ball detent openings 774 are configured to receive balldetents 775. The ball detents 775 extend into the slider channel 769 ofthe handle 770 to hinder or restrict movement of the needle saw wireslider 794 once it is positioned in a non-deployed state (FIG. 17C-1) orfully deployed state (FIG. 17H).

As shown in FIG. 17C-4, which is an enlarged view of the distal end 797of the needle saw wire 792, the needle saw wire 792 includes a tissuecutting member 798, such as a plurality of teeth 798, a penetration tipor piercing member 799 and threads or ridges 800. In some embodiments,the cutting member 798 may be another cutting or abrasive surface or maybe the saw wire itself. With reference to FIG. 17C-1, the saw wire 792is configured to be received in the probe assembly 780 and the teeth 798are configured to be exposed in the window 46 of the probe assembly 780once the window 46 is properly positioned for a release procedure. Insome embodiments, the teeth 798 may be unidirectional. In otherembodiments, the teeth may have a shape as disclosed elsewhere herein.The piercing member 799 is configured to puncture the skin in the palmof the hand during a release procedure and, as described in more detailbelow, is received by the distal handle. The threads 800 secure theneedle saw wire 792 in the distal handle during a procedure.

As indicated in FIG. 17C-5, which illustrates an exploded view of theprobe wire assembly, the probe wire assembly 780 includes an elongatedbody 781 having a window 46 and threads 782, a bump pin 784 and anelongated body mount 785. The elongated body 781 is received in the bodymount 785. The mount 785 and the body 781 are coupled by any appropriatemethod, such as welding. The bump pin 784 is received in the elongatedbody 781 at approximately the window 46 and hinders or restricts forwardmovement of the needle 799 and teeth 798 of the needle saw wire assembly790 when the slider 794 is in a non-deployed position. The threads 782of the elongated body 781 are configured to receive a motion limitingfeature 820, such as a shaft lock assembly 820, as described in moredetail below. The elongated body 781 may be coated with a non-conductivecoating, such as Parylene C or other appropriate material.

With reference to FIG. 17A and as shown in FIGS. 17D and 17E, the systemmay also include an introducer assembly 805 and a motion limitingfeature 820. As indicated in FIGS. 17D-1 and 17D-2, which illustrate twodifferent embodiments of an introducer assembly, the introducer assembly805 may include an introducer stylet 807, a stylet hub 809, anintroducer needle 811 and a needle hub 813. As shown in FIG. 17D-1 andwith reference to FIG. 17A, the stylet 807 and the needle 811 arehollow, elongated bodies configured to receive the probe wire assembly780 and the cutting wire assembly 790. The needle 811 and needle hub 813are also configured to receive the stylet 807 and stylet hub 809. Theintroducer stylet 807 and stylet hub 809 may be integrally formed (seeFIG. 17D-1) or formed separately and subsequently coupled (see FIG.17D-2). In one embodiment, the stylet hub 809 may be generally roundedand the needle hub 813 may be generally cylindrical (see FIG. 17D-1). Inother embodiments, the stylet hub 809 may be generally rectangular andthe needle hub 813 may include cylindrical 813 a, rectangular 813 b anddisc 813 c shaped portions (see FIG. 17D-2). In other embodiments, itcan be appreciated that the hubs 809, 813 may be any other appropriateshape or combination of shapes. The components of the introducerassembly 805 may be made of stainless steel or a steel alloy or otherappropriate material.

As shown in FIGS. 17E-1 to 17E-3, which show an isometric, sideelevation and cross sectional elevation of the motion limiting feature,respectively, and with reference to FIG. 17A, the system 700 may alsoinclude a motion limiting feature 820, such as a shaft lock assembly820. In one embodiment, the shaft lock assembly 820 includes a shaftlock 821, a shaft lock inner portion 822 and a spring (not shown). Thecomponents of the shaft lock assembly may be made of stainless steel ora steel alloy or other appropriate material. The spring may be aMcMaster PN#9001T22. The shaft lock 821 is generally cylindrical andincludes an open proximal end 823, a closed distal end 824 and anopening 825 configured to receive the probe wire assembly 780 or theintroducer needle 811 as detailed herein. The shaft lock inner portion822 is generally mushroom shaped and includes a disc shaped proximalportion 826 with a closed end 827, a cylindrical body with an open end828 and a probe wire assembly opening 829 located in the body andconfigured to receive the probe wire assembly 780 as detailed above. Thelock 821, inner portion 822 and spring are assembled together (thespring is received in the lock 821 and then the inner portion 822 isreceived in the lock 821) and introduced to the probe wire assembly 780or the introducer needle 811. The inner portion is depressed, therebyengaging the spring and aligning the openings 825, 829 such that theprobe wire assembly 780 or the introducer needle 811 can be engaged. Alip 829 a in the inner portion 822 engages the assembly 780 or needle811 and together with the spring, maintains the shaft lock assembly 820in the desired position. To release the shaft lock assembly 820, theinner portion 822 is again depressed, thereby aligning the openings 825,829, and the assembly 820 is removed from the probe wire assembly 780 orthe needle 811.

FIGS. 17F-1 to 17F-4 depict front and back isometric views and explodedviews of those isometric views of the distal handle assembly 830. Asindicated in FIGS. 17F-1 and 17F-2, and with reference to FIG. 17A, thedistal handle assembly 830 includes a handle 831 which is generallycylindrical in shape and may include some contouring. The handle may bemade of polycarbonate or other appropriate material. As shown in FIGS.17F-3 and 17F-4, and with reference to FIGS. 17F-1 and 17F-2, the distalhandle assembly 830 also includes a rear button 832, a linkage arm 833,a lock cam 834 configured to receive the needle saw wire 792, a cam pin835 and a funnel 836 configured to receive the distal end 797 of theneedle saw wire 792.

As indicated in FIG. 17F-3, a first side 831 a of the handle 831 alsoincludes internal cavities 837 configured to receive the components ofthe assembly 830 described above and similarly, and as indicated in FIG.17F-4, a second side 831 b of the handle 831 also includes internalcavities 837 configured to receive the components of the assembly 830described above such that the sides 831 a and 831 b may be joined orcoupled together to form the handle 831. In other embodiments, thehandle 831 is formed as a single piece.

As assembled, prongs 832 a of the button 832 receive a button end 833 aof the linkage arm 833, a cam end 833 b of the arm 833 is received by anarm end 834 a of the cam 834. The cam 834 also includes a cam pinopening 834 b configured to receive the cam pin 835. The funnel 836 isreceived in a cavity 837 a and the button is received in a cavity 837 b.As discussed in more detail below, in use, the needle wire 792 of theneedle wire assembly 790 enters the handle 831 through the funnel 836and engages the cam lock 834, thereby locking the needle in place. Torelease, the button 832 is depressed, thereby engaging the linking arm833 and rotating the cam lock 834 to release the needle wire 792.

FIGS. 17G-1 and 17G-2 show an isometric and exploded view of a portionof a nerve wire assembly 850. With reference to FIG. 17A and as can beunderstood from FIGS. 17G-1 and 17G-2, the nerve wire assembly 850 maybe used with a nerve detection system 500 to aid the user in navigatingthe elongated body 781 in the carpal tunnel region without damaging orcontacting nearby anatomical structures, such as nerves, non-targetligaments, etc. The nerve wire assembly 850 may include a female crimppin 852, a sheath 854, a wire 856 and a shrink wrap 858. In oneembodiment, the crimp pin 852 may be a RS232 female contact pin withinsulation support, the sheath 854 may be FDA rated polyurethane tubing⅛″ OD 1/16″ ID, McMaster PN:5195T616, the wire 856 may be 22AWG strandedwire with FDA rated insulation and the shrink wrap 858 may be FDA ratedheat shrink with adhesive on ID. In some embodiments, the shrink wrap858 may be a coating on the nerve wire assembly 850 rather than aseparate, physical component of the assembly 850. As assembled, thecrimp pin 852 is crimped onto the wire 856, the sheath 854 slides overthe crimp pin and wire, ensuring that the connector slit is visible, yetcovers the connector completely. Then, shrink the shrink wrap 858 overthe sheath, pin and wire. In one embodiment, in use, the distal end 850a of the assembly 850 receives a contact portion (not shown) of a nervedetection device 500 and the proximal end 850 b of the assembly 850 isreceived in the proximal handle 770 such that the needle in the proximalhandle assembly is electrified and the user is notified when the needleis close to a nerve.

FIG. 17H illustrates the proximal handle assembly 765 and the distalhandle assembly 830 operably connected for a release procedure, whereinthe hand is not shown for clarity. As can be understood from FIG. 17H,the needle end 799 of the needle wire assembly 790 punctures the palmand a distal end 797 of the assembly 790 is received in the distalhandle assembly 830 (see FIG. 17H, with reference to FIGS. 17F-3 andF-4). The threads 800 and needle end 799 at the distal end 797 of theassembly 790 engage the internal components 836, 834 of the distalhandle assembly 830, thereby securing the needle wire assembly 790 andthe proximal handle assembly 765 together (see FIG. 17H). Once thedistal end of the needle wire assembly 790 is secured in the distalhandle assembly 830 and the shaft lock assembly 805 has been secured toprevent the introducer assembly 805 and elongated body 781 from exitingthe palm, the user (surgeon) may use a sawing, cutting or other motionto release the TCL, thereby decompressing the median nerve. (see, forexample, FIG. 9E and 9E-1 showing partial release of the TCL or FIGS.16G and 16H). When the procedure is complete, the button 832 of thedistal handle 831 is depressed, thereby disengaging the distal end 797,including the needle end 799, of the needle wire assembly 790 from thedistal handle assembly 830.

In use, the system 700 may be used as an incisionless technique forreleasing the TCL to decompress the median nerve to treat carpal tunnelsyndrome. In other embodiments, the system 700 may be used as anincisionless technique for releasing another ligament or anatomicalstructure to decompress a nerve or other anatomical structure, such asthe plantar fascia ligament to treat plantar fasciitis or to decompressthe ulnar nerve to treat cubital tunnel syndrome or Guyon's canalsyndrome. With cubital tunnel syndrome, the ulnar nerve is compressed bya bone (the humerus bone). The system could shave down this bone torelieve compression on the nerve. Guyon's canal syndrome is compressionof the ulnar nerve. This compression can be caused by a cyst or an ulnarligament, e.g. volnar radio-ulnar ligament.

As can be understood from FIGS. 17D-1 and 17D-2, and with reference toFIG. 5, the introducer stylet 807 and stylet hub 809 are received in theintroducer needle 811 and needle hub 813 of the introducer assembly 805.As can be understood with reference to FIG. 17A, the shaft lock assembly820 may be placed on the assembly 805. The inner portion 822 of theshaft lock assembly 820 is depressed, thereby engaging the spring andaligning the openings 825, 829 such that the needle 811 can be engaged.A lip 829 a in the inner portion 822 engages the needle 811 and togetherwith the spring, maintains the shaft lock assembly 820 in the desiredposition on needle 811 such that it does not hinder entry of theassembly 805 into the wrist. The stylet 807 punctures the skin, providesaccess to the carpal tunnel and prevents coring out of tissue when theintroducer assembly 805 is inserted into the deep wrist two to threecentimeters proximal to the wrist skin crease and just medial to thepalmar longus. Once the introducer assembly 805 is positioned in thedeep wrist, the stylet 807 and stylet hub 809 are withdrawn from theintroducer needle 811 and needle hub 813 and the needle 811 and hub 813and shaft lock assembly 820 remain in place.

As can be understood from FIGS. 17C-1 to 17C-5, the needle wire assembly790 is received in the handle 770 and the probe wire assembly 780,thereby resulting in the proximal handle assembly 765. In someembodiments, and with reference to FIG. 18, the proximal handle assembly765 may also be electrically coupled to a neuro-monitoring device 500via a nerve wire assembly 850 (see the wire 550 of FIG. 18). The nervewire assembly 850 supplies electrical current to the probe wire assembly780 such that during insertion of the elongated body 781 into the carpaltunnel, such that contact between the elongated body and a nerve willelicit patient response, e.g. sensory and/or motor. This patientresponse aids the surgeon in locating the nerve to support safepositioning of the device. As indicated in FIG. 17A, the proximal handleassembly 765 may then be inserted into the introducer assembly 805 andthe shaft lock assembly 820 transitions from the introducer assembly 805to the proximal handle assembly 765. The inner portion 822 of the shaftlock assembly 820 is depressed, thereby engaging the spring and aligningthe openings 825, 829 such that the lock assembly 820 can be removedfrom the needle 811 and a thread 782 of the probe wire assembly 780 canbe engaged. A lip 829 a in the inner portion 822 engages the thread 782and together with the spring, maintains the shaft lock assembly 820 inthe desired position on the elongated body 781 of the probe wireassembly 780. With reference to FIG. 6A, the elongated body 781 of theprobe wire assembly 781 is then passed through the carpal tunnelparallel to the nerve and flexor tendons proximal to distal. As shown inFIG. 17C-5, the elongated body 781 has a ball tip or blunt probe at adistal end 788 similar to nerve stimulators to prevent impaling thenerve or tendons. Once the assembly 765 has been properly positionedrelative to the TCL, with the aid of a nerve detection device 500, theslider 794 may be advanced from a non-deployed position (see FIG. 17A)to a deployed position (see FIG. 17H), thereby exposing the cuttingsurface or teeth 798 of the needle wire assembly 790 in the window 46.The needle end 799 of the needle wire assembly 790 punctures the palmand a distal portion of the assembly 790 is received in the distalhandle assembly 830 (see FIG. 17H, with reference to FIGS. 17F-3 andF-4). The threads 800 and needle end 799 at the distal end of theassembly 790 engage the internal components 836, 834 of the distalhandle assembly 830, thereby securing the needle wire assembly 790 andthe proximal handle assembly 765 together. (see FIG. 17H). The shaftlock assembly 805 is repositioned as needed on the thread 782 of theelongated body 781 such that the introducer assembly 805 and theelongated body 781 do not exit the palm. The distal end of the needlewire assembly 790 is secured in the distal handle assembly 830 and theshaft lock assembly 820 is secured to prevent the introducer needle 811and elongated body 781 from exiting the palm. This reduces the openingor puncture made in the patient's palm. The user (surgeon) may use asawing, cutting or other motion to release the TCL, therebydecompressing the median nerve (see, for example, FIG. 9E and 9E-1showing partial release of the TCL and FIGS. 16G and 16H). When theprocedure is complete, the button 832 of the distal handle 831 isdepressed, thereby disengaging the distal end 797, including the needleend 799, of the needle wire assembly 790 from the distal handle assembly830. The distal handle 831 may be placed to the side or discarded. Theslider 794 of the proximal handle assembly 765 is retracted from thedeployed state into the non-deployed state, thereby withdrawing thecutting member 798 of the needle wire assembly 790 from the window 46.The shaft lock assembly 820 is disengaged from the elongated body 781and re-engaged with the introducer needle 811. The proximal handleassembly 765 is withdrawn from the introducer needle 811 and hub 813.The introducer needle 811 and hub 813 are withdrawn from the wrist.

In some embodiments, the hand may be immobilized in a hand immobilizersystem, such as the handboard assembly 705, thereby reducing the chanceof movement of the hand out of its position under the TCL, therebyincreasing control of the device during the release procedure. Thehandboard assembly 705 is assembled as described above to place the handinto a proper position to conduct the procedure. The hand may beinitially secured by the tabs 754 and may be further secured byadditional straps to further immobilize the hand.

For a discussion of another embodiment of a system where the elongatedbody and the introducer do not exit the exit port of the hand, referenceis now made to FIG. 18, which depicts a release system in which neitherthe distal end of the elongated body nor the introducer exit the exitpoint in the palm of the hand.

FIG. 18 illustrates an embodiment with many similar features asdescribed above with reference to FIGS. 17A-17H. In general, thehandboard assembly 705, the nerve detection/stimulator wiring assembly,the introducer assembly 805, shaft lock assembly 820, proximal handleassembly 765 and distal handle assembly 830 are as described above withrespect to FIGS. 17A-17H. As can be understood from FIG. 18, thehandboard assembly 705 includes comparable elements except only onenerve detection system cavity 714 is shown and the drape assembly 750does not include tabs. In addition, a nerve detection system 500 isillustrated. FIG. 18 also illustrates a wire 550 at the proximal end 771of the proximal handle assembly 765 which may be used with the nervedetection system. The distal handle assembly 830 illustrates a differentembodiment of the handle, wherein the shape is similar to the proximalhandle and the proximal end with the release button has a slope. Thefastening members (e.g. screws) that join the two sides of the handlecan also be seen. The embodiment of the system as depicted in FIG. 18operates as described above with respect to FIGS. 17A-17H.

As discussed above, the cutting member 45 may extend from or about thewindow 46 to release the TCL. For a discussion of some embodiments of acutting member 45 that may be used according to the present disclosure,reference is now made to FIGS. 19A-19E, which illustrate variousadditional embodiments of a cutting member 45.

As shown in FIG. 19A, in one embodiment, the cutting member 45 may be arotating cutting wire or other rotating abrasive surface. Thisembodiment of the cutting member 45 is inserted into the elongated body40 and advanced such that it is exposed in the window 46 once the windowis properly positioned under the ligament. The cutting member 45 isrotated like a screw. The rotation of the cutting member 45 within theelongated body 40 can be accomplished by either manual or mechanicalenergy. The rotating blades or threads 1905 of the cutting member 45release a ligament 1910, such as the TCL, plantar fascia or otheranatomical structure, to relieve compression of a nerve, such as themedian nerve, or other nerve in need of decompression, such as the ulnarnerve.

As can be understood from FIG. 19B, in one embodiment, the cuttingmember 45 is a hydraulic cutting wire or water jet. The cutting member45 may include a water delivery body 1915 having a water jet 1920, and aprotective shield 1925. In use, the elongated body 40 is positioneddorsal to (underneath) the ligament and the water delivery body 1915including a water jet 1920 and the protective shield 1925 are advancedto the window 46 of the elongated body 40. The water jet 1920 isactivated (via delivery of water or other appropriate liquid, via thewater delivery tube, which may have a water inlet system at a proximalend of the elongated body) and produces a high velocity stream of waterthat cuts the TCL through a precise and controlled release. It can beappreciated that in other embodiments, the water delivery body 1915,water jet 1920 and/or the protective shield 1925 may be integrated withthe elongated body 40 rather than being separate or individual pieces.

As shown in FIG. 19C, in one embodiment, the cutting member 45 may be aspring assisted-reciprocating cutting member. The cutting member may bea wire or other abrasive material. In this embodiment, the elongatedbody 40 includes a spring feature 1930 in the distal end 1935 of thebody 40. In use, the elongated body 40 is positioned dorsal to(underneath) the ligament and as the cutting member 45 is advanceddistally, the cutting member 45 engages the spring feature 1930, therebycausing a reciprocating cutting motion in the proximal direction torelease the TCL. This spring feature 1930 is included in the elongatedbody 40 and is compatible with a number of different embodiments of thecutting member 45 as disclosed herein.

As can be understood from FIGS. 19D-1 to 19D-3, in one embodiment, thecutting member 45 may be a circular cutting wire 45. The cutting member45 may be a stand-alone cutting member 45 or may be inserted into theelongated body 45 and the teeth 1940 may be exposed in the window 46. Asshown in FIG. 19D-1, the cutting member 45 may include a body 1945having a proximal end 1946 and a distal end 1947. The proximal end 1946includes a handle feature 1950 and an actuation mechanism 1955. Asindicated in FIGS. 19D-2 and 19D-3, the actuation mechanism 1955releases a cap 1960 at the distal end 1947 of the body 1945 via alinking bar 1961, thereby exposing the teeth 1940 or other abrasivesurface of the cutting member 45. That is, as actuation mechanism 1955 bis retracted proximally, the cap 1960 is extended distally and actuationmechanism 1955 a is extended distally, thereby creating a reciprocatingor circular-like sawing or cutting motion such that the teeth 1940,which may form a “bow” shape, and which may be exposed in the window 46(not shown), can release the TCL.

As shown in FIGS. 19E-1 and 19E-2, in one embodiment, the cutting member45 may be a cutting wire 1965 utilizing RF energy. An RF energy device(not shown) may be operably attached to the cutting wire 1965 and thedevice may be located at a proximal end of the elongated body 40. Asshown in FIG. 19E-1, once the elongated body is properly positioned, thecutting wire 1965 is advanced through the elongated body 40 to thewindow 46. As shown in FIG. 19E-2, the cutting wire 1965 is advancedthrough the window 46. The RF energy device provides RF energy to thecutting wire 1965 in a controlled and directed manner in order torelease the ligament 1910.

For a discussion of various embodiments of a nerve detection system orneuro monitoring system 500, reference is now made to FIGS. 20A-20F,which illustrate various embodiments of a nerve detection system thatmay be used with a release system as disclosed herein. In embodimentswhich utilize a nerve detection system, the nerve detection system helpsto enable the release system to be a “closed release system” or anincisionless system because the user can safely navigate the releasesystem within the carpal tunnel region and surrounding areas withoutmaking an incision.

As discussed above, the elongated body 40 may have neuro monitoringfeatures, such as a supple metal probe, that may be used in conjunctionwith neuro monitoring systems or nerve detection systems 500 to helpguide the elongated body 40 through the carpal tunnel area withoutharming nearby nerves and such that the body 40 is properly positionedunder the TCL. In some embodiments, the neuro monitoring system 500 maybe the system offered by Cadwell Laboratories, Inc., Kennewick, Wash.,Biotronic, Ann Arbor, MI or Medtronic, Minneapolis, MN (such as theVari-Stim III Nerve Locator). The supple metal probe, such as the bluntprobe tip 42, is also attached to a nerve monitor to assist the surgeonin navigation under the TCL. It can be appreciated that the probe mayalso be a separate instrument from the elongated body. The surgeon canidentify median nerve irritation and accordingly alter the course of thebody 40 with hand movements or remove the body 40 and start over again.

As shown in FIG. 20A, in one embodiment, the nerve detection system 500is a nerve locating device. This device 500 is a nerve locating systemthat is placed external to the patient's hand 10 and includes a nervestimulator 2005 and a visualization device 2010, which may be a screen,monitor or other appropriate device. Stimulation is applied by thestimulator 2005 to the nerves 2015 and the device 500 detects magneticfields from the nerves 2015 and translates them into a lighted mappingof the nerve location, which is shown on the visualization device 2010.That is, the nerves 2015 are stimulated using an external electricalcurrent such as a surface electrode which creates an increasedelectrical signal in the nerves. The device then detects the signal andenables a visual mapping of the nerves. An elongated body 40 of arelease system as disclosed herein may be inserted through an introducer35 and deployed at a safe distance from the nerves as determined bylooking at the nerve location on the visualization device 2010.

As indicated in FIGS. 20B-1 to 20C, in some embodiments, the nervedetection system 500 is or includes a durometer or other similarhardness tester 2020. The durometer 2020 may include a pin 2021, aspring 2022 and a force sensor 2023. The durometer 2020 measuresvariations in material hardness and, accordingly, can detect or identifythe differences in hardness of anatomical structures 2030, such asnerves 2015, ligaments 2025, tendons, bones, or etc. As shown in FIGS.20B-2 and 20B-3, the durometer 2020 may be operably connected to oraxially extend from a distal end of the elongated body 40. As shown inFIG. 20C, a plurality of durometers 2020 may be operably connected orextend transversely from a distal end of the elongated body 40.

One or more durometers 2020 may be operably connected to the elongatedbody 40 and can detect if the body 40 comes in contact with a nerve 2015or other anatomical structure 2030. As shown in FIG. 20B-2, in anon-compressed (pre-contact) state, the spring 2022 is in an expandedstate. As indicated in FIG. 20B-3, if the pin 2021 comes into contactwith an anatomical structure 2030, the pin 2021 will compress the spring2022, which compression is measured by the force sensor 2023. Becauseanatomical structures have varying degrees of hardness (e.g. bones areharder than nerves), the durometer 2020 will help to detect if theelongated body 40 of the release system is being (or will be) insertedtoo close to a nerve. In such a case, the elongated body 40 may beredirected or reinserted.

As shown in FIG. 20D, in one embodiment, the nerve detection system 500may be an electromagnetic sensor 2035. The sensor 2035 is operablyconnected to the elongated body and can detect proximity to the nerves2015. A nerve conveys information in the form of electrochemicalimpulses (known as nerve impulses or action potentials) carried by theindividual neurons that make up the nerve. The detection by the sensor2035 is accomplished by sensing differences in electromagnetic fieldsemanating from the nerves and may offer a warning, e.g. a signal, thatcontact with a nerve is imminent. This detection allows the surgeon toreposition the elongated body 40 without coming in contact with thenerve.

As indicated in FIG. 20E, in one embodiment, the nerve detection system500 may be an ultrasound probe 2040 and associated visualization device2045, which may be a screen, monitor or other appropriate device. Theprobe 2040 is integrated with the elongated body 40 of the releasesystem to enable ultrasound imaging within the carpal tunnel 5 and hand.The probe 2040 operates like a traditional ultrasound transducer but issized to be compatible with the elongated body 40 and the releasesystem. As the surgeon is advancing the system within the carpal tunnel,the ultrasound probe 2040 will transmit images to the visualizationdevice 2045 and the surgeon can advance or alter the course ofadvancement of the elongated body 40 in order to avoid contact and/orinjury of neural and vascular structures.

As shown in FIG. 20F, in one embodiment, the nerve detection system 500may be a catheter 2050 with nerve stimulation contact points 2055. Thecatheter 2050 may be a steerable catheter that is advanced through theelongated body 40. In one embodiment, the catheter 2050 is advancedthrough the elongated body 40 while the cutting member 45 is notassembled within the elongated body 40. The catheter 2050 can bedirectionalized and advanced toward suspected nerve location(s) in orderto identify the location(s) and direct the elongated body 40 away fromsuch location. The catheter 2050 exits through the window 46 of theelongated body 40 and the catheter 2050 may be removed once theelongated body 40 is properly positioned in the carpal tunnel area asdescribed elsewhere herein.

In use, the systems and methods disclosed herein may be used as anincisionless technique for releasing the TCL to decompress the mediannerve. In one embodiment, a 14 gauge or similar sized needle introduceris inserted into the deep wrist three or four centimeters proximal tothe wrist skin crease and just medial to the palmar longus. An elongatedbody is then passed through the carpal tunnel parallel to the nerve andflexor tendons proximal to distal. The elongated body has a ball tip orblunt probe similar to nerve stimulators to prevent impaling the nerveor tendons. The distal end of the body (or other associated device, e.g.the sled member) may assume a curled shape such that when it is passedthrough the ligament towards or into the palm, the tip trajectory isupwards towards the palm skin. A probe is attached to a nerve monitor toassist the surgeon in navigation under the TCL. The surgeon can identifymedian nerve irritation and accordingly alter the course of theelongated body with hand movements or remove the elongated body andstart over again. In various embodiments the elongated body can be atleast partially coated with a non-conductive material such that only aportion of the diameter of the body is exposed for nerve stimulation.The elongated body is passed under the TCL to approximately the palmskin between the third and fourth fingers on the medial side of thenerve. The palm skin may be pierced by a sharp wire or stylet insertedthrough the elongated body (or alternative cutting instrument), thesharp wire extending beyond the blunt tip or probe tip of the elongatedbody once the probe is identified underneath the skin surface.Alternatively, the ball tip can emit a light that can be identified inthe subcutaneous tissues and a small stab wound made to retrieve theprobe and deliver it to the surface. Accordingly, the surgeon has passedthe elongated body under the carpal tunnel ligament on the ulnar/medialside of the nerve using intraoperative nerve studies to safely navigatethrough two needle puncture sites. The surgeon may use an embodiment ofthe elongated body that includes a cutting member or the surgeon maypass other cutting wires or instruments over or through the elongatedbody for the purpose of cutting the carpal tunnel ligament using aflossing, sawing, cutting or single pull through movement. In someembodiments, the hand may be immobilized in a hand immobilizer system,thereby reducing the chance of movement of the elongated body out of itsposition under the TCL.

Some or all of the various components, e.g., the introducer, elongatedbody, cutting member, proximal handle assembly, distal handle assembly,etc., may be provided in the form of a packaged kit provided in one ormore sterilized, sealed packages from the manufacturer along withinstructions provided with the kit or on a website. Some or all of thevarious components of the kit may be disposable. The instructionsprovided with the kit or on a website may be assembly instructionsrelated to some or all of the various components of the kit and/orinstructions for use of some or all of the components in a releaseprocedure. In one embodiment, a kit for releasing a ligament may includean introducer including a stylet needle, a stylet hub, an introducerneedle and an introducer hub. A first handle assembly including: a firsthandle member, an elongated body including a blunt tip, a window, and adistal end and a proximal end and a cutting member including a piercingmember at a distal end of the cutting member may also included. The kitmay also include a second handle configured to receive a distal end ofthe cutting member of the first handle assembly. The kit may alsoinclude a motion limiting feature configured to removably couple withthe elongated body and/or a handboard assembly, the handboard assemblycomprising a baseplate chassis, a flexboard and a drape assembly. Atleast some components of the kit may be disposable.

All directional references (e.g., proximal, distal, upper, lower,upward, downward, left, right, lateral, front, back, top, bottom, above,below, vertical, horizontal, clockwise, and counterclockwise) are onlyused for identification purposes to aid the reader's understanding ofthe present invention, and do not create limitations, particularly as tothe position, orientation, or use of the invention. Connectionreferences (e.g., attached, coupled, connected, and joined) are to beconstrued broadly and may include intermediate members between acollection of elements and relative movement between elements unlessotherwise indicated. As such, connection references do not necessarilyinfer that two elements are directly connected and in fixed relation toeach other. The exemplary drawings are for purposes of illustration onlyand the dimensions, positions, order and relative sizes reflected in thedrawings attached hereto may vary.

The above specification and examples provide a complete description ofthe structure and use of exemplary embodiments of the invention.Although various embodiments of the invention have been described abovewith a certain degree of particularity, or with reference to one or moreindividual embodiments, those skilled in the art could make numerousalterations to the disclosed embodiments without departing from thespirit or scope of this invention. Other embodiments are thereforecontemplated. It is intended that all matter contained in the abovedescription and shown in the accompanying drawings shall be interpretedas illustrative only of particular embodiments and not limiting. Changesin detail or structure may be made without departing from the basicelements of the invention as defined in the following claims.

1. A system for releasing a ligament, the system comprising: a proximalhandle; a tubular body comprising a proximal end and a distal end, thehandle coupled to the proximal end; and a flexible body extendingthrough the tubular body and comprising a tissue cutting portion, theflexible body longitudinally displaceable relative to the tubular bodyto move the tissue cutting portion between a non-deployed state and adeployed state.
 2. The system of claim 1, wherein the tissue cuttingportion includes a plurality of teeth or an abrasive surface.
 3. Thesystem of claim 1, wherein the tissue cutting portion includes an RFenergy cutter or a water jet.
 4. The system of claim 1, wherein theflexible body is longitudinally displaced relative to the tubular bodyduring a tissue cutting motion.
 5. The system of claim 1, wherein theflexible body and tubular body are moved together during a tissuecutting motion.
 6. The system of claim 1, wherein the flexible body isaxially rotationally displaced relative to the tubular body during atissue cutting motion.
 7. The system of claim 1, wherein the tubularbody further comprises a window, wherein, when the flexible body islongitudinally displaced relative to the tubular body to move the tissuecutting portion from the non-deployed state to the deployed state, thecutting portion moves from being generally hidden within the tubularbody to being generally exposed in the window.
 8. The system of claim 1,wherein the tubular body further comprises a window, wherein, when theflexible body is longitudinally displaced relative to the tubular bodyto move the tissue cutting portion from the non-deployed state to thedeployed state, the cutting portion moves from being generally recessedwithin the tubular body to being generally exposed in the window.
 9. Thesystem of claim 8, wherein, when the cutting portion is in the deployedstate, the cutting portion assumes a bow-like arrangement with thetubular body.
 10. The system of claim 1, further comprising an actuatornear the proximal end of the tubular body that causes the cuttingportion to move between the non-deployed state and the non-deployedstate.
 11. The system of claim 10, wherein the handle includes theactuator.
 12. The system of claim 1, further comprising a distal handleconfigured to operably couple to the distal end of the tubular body. 13.The system of claim 12, wherein the flexible body further comprises adistal end comprising a tissue penetration tip that moves from arecessed state to a tissue penetration state when the flexible body islongitudinally displace relative to the tubular body.
 14. The system ofclaim 13, wherein, when the penetration tip is in the recessed state,the tissue cutting portion is in the non-deployed state.
 15. The systemof claim 13, wherein, when the penetration tip is in the tissuepenetration state, the tissue cutting portion is in the deployed state.16. The system of claim 13, wherein the distal handle is configured tooperably couple to the distal end of the tubular body by being directlyconnected to the distal end of the flexible body when the penetrationtip is in the penetration state.
 17. The system of claim 13, furthercomprising an adjustable lock supported on the tubular body that limitsa distal cutting stroke displacement of the system.
 18. The system ofclaim 17, wherein the distal cutting stroke displacement of the systemcan be limited by the adjustable lock such that the tubular body willextend through an exit hole created in the palm by the penetration tip.19. The system of claim 1, wherein the flexible body further comprises adistal end comprising a tissue penetration tip that moves from arecessed state to a tissue penetration state when the flexible body islongitudinally displace relative to the tubular body.
 20. The system ofclaim 19, wherein, when the penetration tip is in the recessed state,the tissue cutting portion is in the non-deployed state.
 21. The systemof claim 19, wherein, when the penetration tip is in the tissuepenetration state, the tissue cutting portion is in the deployed state.22. The system of claim 19, further comprising an adjustable locksupported on the tubular body that limits a distal cutting strokedisplacement of the system.
 23. The system of claim 22, wherein thedistal cutting stroke displacement of the system can be limited by theadjustable lock such that the tubular body will extend through an exithole created in the palm by the penetration tip.
 24. The system of claim1, further comprising a nerve sensing system electrically coupled to thetubular body or flexible body.
 25. The system of claim 25, wherein thenerve sensing system is configured to sense nerve impulses or actionpotentials.
 26. The system of claim 25, wherein the nerve sensing systemincludes an ultrasound probe operably coupled to the tubular body. 26.The system of claim 25, wherein the nerve sensing system includes ahardness sensor operably coupled to the tubular body.
 27. A method ofreleasing a ligament, the method comprising: percutaneously penetratingat a first location with a tubular body; positioning the tubular bodyadjacent the ligament; employing a nerve sensing system to position atissue cutting portion away from a nerve, the tissue cutting portionbeing part of a flexible body longitudinally displaceable relative tothe tubular body between a non-deployed state and a deployed state ofthe tissue cutting portion; causing the tissue cutting portion tolongitudinally displace from the non-deployed state to the deployedstate; and releasing the ligament with the tissue cutting portion. 28.The method of claim 27, wherein releasing the ligament with the tissuecutting portion includes causing the tissue cutting portion tolongitudinally displace relative to the tubular body.
 29. The method ofclaim 27, wherein releasing the ligament with the tissue cutting portionincludes causing the tissue cutting portion and the tubular body tolongitudinally displace together.
 30. The method of claim 27, whereinreleasing the ligament with the tissue cutting portion includes causingthe tissue cutting portion to axially rotationally displace relative tothe tubular body.
 31. The method of claim 27, wherein the tissue cuttingportion includes a plurality of teeth or an abrasive surface.
 32. Themethod of claim 27, wherein the tissue cutting portion includes an RFenergy cutter or a water jet.
 33. The method of claim 27, wherein thetubular body comprises a window, wherein, when the flexible body islongitudinally displaced relative to the tubular body to move the tissuecutting portion from the non-deployed state to the deployed state, thecutting portion moves from being generally hidden within the tubularbody to being generally exposed in the window.
 34. The method of claim27, wherein the tubular body comprises a window, wherein, when theflexible body is longitudinally displaced relative to the tubular bodyto move the tissue cutting portion from the non-deployed state to thedeployed state, the cutting portion moves from being generally recessedwithin the tubular body to being generally exposed in the window. 35.The method of claim 34, wherein, when the cutting portion is in thedeployed state, the cutting portion assumes a bow-like arrangement withthe tubular body.
 36. The method of claim 27, further comprisingoperably coupling a distal handle to a distal end of the flexible bodyor a distal end of the tubular body.
 37. The method of claim 26, furthercomprising causing the distal end of the flexible body to percutaneouslypenetrate at a second location.
 38. The method of claim 37, furthercomprising causing the distal end of the tubular body to percutaneouslypenetrate at the second location.
 39. The method of claim 37, whereinthe distal end of the flexible body percutaneously penetrating at asecond location includes causing a tissue penetration tip of the distalend of the flexible body to move from a recessed state to a tissuepenetration state when the flexible body is longitudinally displacerelative to the tubular body.
 40. The method of claim 39, wherein, whenthe penetration tip is in the recessed state, the tissue cutting portionis in the non-deployed state.
 41. The method of claim 39, wherein, whenthe penetration tip is in the tissue penetration state, the tissuecutting portion is in the deployed state.
 42. The method of claim 27,further comprising adjusting a lock supported on the tubular body tolimit a distal cutting stroke displacement tissue cutting portion.
 43. Asystem for releasing a ligament, the system comprising: an introducercomprising a distal end and a proximal end; a flexible body comprising afirst end, a second end and a length extending between the first end andthe second end, the length forming a loop distally extending from thedistal end of the introducer and configured to have the ligament in theloop, the length comprising a tissue cutting portion, the first end andthe second end proximally extending from the proximal end of theintroducer.
 44. The system of claim 43, wherein the tissue cuttingportion includes a plurality of teeth or an abrasive surface.
 45. Thesystem of claim 43, further comprising an elongated body configured tobe extended through the introducer proximal to distal and engage thefirst end and pull the first end around the ligament and through theintroducer to form the loop such that the first end is adjacent thesecond end extending proximally from the proximal end of the introducer,the elongated body including a first engagement feature configured toengage a second engagement feature on the first end.
 46. The system ofclaim 45, wherein the first engagement feature includes a hook and thesecond engagement feature includes a ball.
 47. The system of claim 45,wherein the elongated body includes forceps.
 48. The system of claim 43,further comprising a first handle operably coupled to the first end anda second handle operably coupled to the second end.
 50. The system ofclaim 43, further comprising a nerve detection system coupled to theflexible body.
 51. A method for releasing a ligament, the systemcomprising: percutaneously penetrating at a first location with anintroducer comprising a distal end and a proximal end; providing aflexible body comprising a first end, a second end and a lengthextending between the first end and the second end and comprising atissue cutting portion; routing the first end distally through theintroducer, around the ligament and proximally back through theintroducer such that the length forms a loop around the ligament, theloop distally extending from the distal end of the introducer, the firstend and the second end proximally extending from the proximal end of theintroducer; and employing the tissue cutting portion to release theligament.
 52. The method of claim 51, wherein the tissue cutting portionincludes a plurality of teeth or an abrasive surface.
 53. The method ofclaim 51, further comprising employing an elongated body configured tobe extended through the introducer proximal to distal to engage thefirst end and pull the first end around the ligament and through theintroducer to form the loop.
 54. The method of claim 51, furthercomprising securing a handle to at least one of the first end or secondend.
 55. The method of claim 51, further comprising employing a nervesensing system to position the tissue cutting portion away from a nerve.56. A handboard assembly for securing a hand and forearm of a patientundergoing a carpal tunnel surgery, the assembly comprising: a chassisbase including a first end and a second end; and a flex board includinga third end, a fourth end, a first planar region adjacent the third end,a second planar region adjacent the fourth end and a flex region betweenthe first planar region and the second planar region, the third endoperably coupled to the first end and the fourth end operably coupled tothe second end, the flex region configured to result in a bend in theflex board when the first planar region and the second planar region areeach caused to assume an incline relative to the chassis base.
 57. Theassembly of claim 56, wherein the first planar region is adapted toreceive the hand and the second planar region is adapted to receive theforearm.
 58. The assembly of claim 56, wherein the first planar regionincludes a finger receiving portion with a finger securing mechanism anda thumb receiving portion with a thumb securing mechanism, and thesecond planar region includes a forearm securing mechanism.
 59. Theassembly of claim 57, wherein at least one of the finger securingmechanism, thumb securing mechanism, or the forearm securing mechanismincludes a strap arrangement.
 60. The assembly of claim 57, wherein thestrap arrangement includes hook and loop regions.